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3. Heterogeneity of treatment effect of higher dose dexamethasone by geographic region (Europe vs. India) in patients with COVID-19 and severe hypoxemia – a post hoc evaluation of the COVID STEROID 2 trial

Author

Munch, Marie W., Myatra, Sheila N., Tirupakuzhi Vijayaraghavan, Bharath Kumar, Saseedharan, Sanjith, Benfield, Thomas, Wahlin, Rebecka R., Rasmussen, Bodil S., Andreasen, Anne Sofie, Poulsen, Lone M., Cioccari, Luca, Khan, Mohd S., Kapadia, Farhad, Divatia, Jigeeshu V., Brøchner, Anne C., Bestle, Morten H., Helleberg, Marie, Michelsen, Jens, Padmanaban, Ajay, Bose, Neeta, Møller, Anders, Borawake, Kapil, Kristiansen, Klaus T., Shukla, Urvi, Chew, Michelle S., Dixit, Subhal, Ulrik, Charlotte S., Amin, Pravin R., Chawla, Rajesh, Wamberg, Christian A., Shah, Mehul S., Darfelt, Iben S., Jørgensen, Vibeke L., Smitt, Margit, Granholm, Anders, Kjær, Maj-Brit N., Møller, Morten H., Meyhoff, Tine S., Vesterlund, Gitte K., Hammond, Naomi E., Micallef, Sharon, Bassi, Abhinav, John, Oommen, Jha, Anubhuti, Cronhjort, Maria, Jakob, Stephan M., Gluud, Christian, Lange, Theis, Kadam, Vaijayanti, Marcussen, Klaus V., Hollenberg, Jacob, Hedman, Anders, Nielsen, Henrik, Schjørring, Olav L., Jensen, Marie Q., Leistner, Jens W., Jonassen, Trine B., Kristensen, Camilla M., Clapp, Esben C., Hjortsø, Carl J.S., Jensen, Thomas S., Halstad, Liv S., Bak, Emilie R.B., Zaabalawi, Reem, Metcalf-Clausen, Matias, Abdi, Suhayb, Hatley, Emma V., Aksnes, Tobias S., Gleipner-Andersen, Emil, Alarcón, A.Felix, Yamin, Gabriel, Heymowski, Adam, Berggren, Anton, la Cour, Kirstine, Weihe, Sarah, Pind, Alison H., Engstrøm, Janus, Jha, Vivekanand, Venkatesh, Balasubramanian, Perner, Anders, Hammond, Naomi, Munch, Marie Warrer, and Møller, Morten Hylander

Published
2024
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7. Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia

Author

Granholm, Anders, Kjær, Maj-Brit Nørregaard, Munch, Marie Warrer, Myatra, Sheila Nainan, Vijayaraghavan, Bharath Kumar Tirupakuzhi, Cronhjort, Maria, Wahlin, Rebecka Rubenson, Jakob, Stephan M., Cioccari, Luca, Vesterlund, Gitte Kingo, Meyhoff, Tine Sylvest, Helleberg, Marie, Møller, Morten Hylander, Benfield, Thomas, Venkatesh, Balasubramanian, Hammond, Naomi E., Micallef, Sharon, Bassi, Abhinav, John, Oommen, Jha, Vivekanand, Kristiansen, Klaus Tjelle, Ulrik, Charlotte Suppli, Jørgensen, Vibeke Lind, Smitt, Margit, Bestle, Morten H., Andreasen, Anne Sofie, Poulsen, Lone Musaeus, Rasmussen, Bodil Steen, Brøchner, Anne Craveiro, Strøm, Thomas, Møller, Anders, Khan, Mohd Saif, Padmanaban, Ajay, Divatia, Jigeeshu Vasishtha, Saseedharan, Sanjith, Borawake, Kapil, Kapadia, Farhad, Dixit, Subhal, Chawla, Rajesh, Shukla, Urvi, Amin, Pravin, Chew, Michelle S., Wamberg, Christian Aage, Bose, Neeta, Shah, Mehul S., Darfelt, Iben S., Gluud, Christian, Lange, Theis, and Perner, Anders

Published
2022
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8. Dexamethasone 12 mg versus 6 mg for patients with COVID-19 and severe hypoxaemia: a pre-planned, secondary Bayesian analysis of the COVID STEROID 2 trial

Author

Granholm, Anders, Munch, Marie Warrer, Myatra, Sheila Nainan, Vijayaraghavan, Bharath Kumar Tirupakuzhi, Cronhjort, Maria, Wahlin, Rebecka Rubenson, Jakob, Stephan M., Cioccari, Luca, Kjær, Maj-Brit Nørregaard, Vesterlund, Gitte Kingo, Meyhoff, Tine Sylvest, Helleberg, Marie, Møller, Morten Hylander, Benfield, Thomas, Venkatesh, Balasubramanian, Hammond, Naomi E., Micallef, Sharon, Bassi, Abhinav, John, Oommen, Jha, Vivekanand, Kristiansen, Klaus Tjelle, Ulrik, Charlotte Suppli, Jørgensen, Vibeke Lind, Smitt, Margit, Bestle, Morten H., Andreasen, Anne Sofie, Poulsen, Lone Musaeus, Rasmussen, Bodil Steen, Brøchner, Anne Craveiro, Strøm, Thomas, Møller, Anders, Khan, Mohd Saif, Padmanaban, Ajay, Divatia, Jigeeshu Vasishtha, Saseedharan, Sanjith, Borawake, Kapil, Kapadia, Farhad, Dixit, Subhal, Chawla, Rajesh, Shukla, Urvi, Amin, Pravin, Chew, Michelle S., Wamberg, Christian Aage, Gluud, Christian, Lange, Theis, and Perner, Anders

Published
2022
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9. Characteristics and outcomes of medical emergency team calls in a Swiss tertiary centre – a retrospective observational study

Author

Messmer Annina S., Annina Elmer, Roger Ludwig, Pfortmueller Carmen A., Cioccari Luca, and Schefold Joerg C.

Subjects
Medicine
Abstract

AIMS OF THE STUDY: To describe reasons for medical emergency team (MET) activation over time, to analyse outcomes, and to describe the circadian distribution of MET calls and Intensive Care Unit (ICU) admissions following MET activation. METHODS: Monocentric retrospective observational study of prospectively collected data on all MET calls between 1st of January 2012 until 31st of May 2019. We analysed data on baselines, referring wards, and disposition of all MET patients. In addition, we allocated all MET calls to the hourly intervals over the 24-hour cycle of the day in order to identify peak times of team activation. RESULTS: A total of 4068 calls in 3277 patients (37% female, n = 1210) were analysed. The mean age was 65.9 years (± 15.7). The MET dose (defined as MET calls/1000 hospital admissions) remained relatively stable over the years with a median of 8.0 calls/1000 hospitalisations (interquartile range [IQR] 7.0–10.0). A total of 2526 calls (62%) occurred out of hours (17:00 to 8:00). The hourly rate of MET activations was greatest during the evening shift (33.8% of calls in seven hours), followed by the day shift (35.8% calls in nine hours) and night shift (30.4% in eight hours). Over the years, staff concern was the main reason for a MET call (n = 1192, 34%), followed by low peripheral oxygen saturation (SpO2) not responding to oxygen therapy (n = 776, 22%). Abnormal respiratory rate was a trigger to call the MET in 44 cases (1.3%), and was not documented prior to 2017. Overall, in-hospital mortality was 22%. CONCLUSION: While most common reasons for MET calls over the years were staff concern and low SpO2, abnormal respiratory rate was the least frequent, but increased after the introduction of the quick sequential organ failure assessment (qSOFA) in 2016. Most MET calls occurred out of hours with peak hours during the evening shift, highlighting the importance of resource allocation during this shift when planning to introduce a MET system in a hospital. In-hospital mortality after a MET call was 22%.

Published
2022
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11. Cytokine and lipid metabolome effects of low-dose acetylsalicylic acid in critically ill patients with systemic inflammation: A pilot, feasibility, multicentre, randomised, placebo-controlled trial

Author

Cioccari, Luca, Luethi, Nora, Duong, Thy, Ryan, Eileen, Cutuli, Salvatore L, Lloyd-Donald, Patryck, Eastwood, Glenn M, Peck, Leah, Young, Helen, Vaara, Suvi T, French, Craig J, Orford, Neil, Dwivedi, Jyotsna, Lankadeva, Yugeesh R, Bailey, Michael, Reid, Gavin E, and Bellomo, Rinaldo

Published
2020

12. Haemodynamic effect of a 20% albumin fluid bolus in postcardiac surgery patients

Author

Cutuli, Salvatore L, Bitker, Laurent, Osawa, Eduardo A, O'Brien, Zachary, Canet, Emmanuel, Yanase, Fumitaka, Ancona, Paolo, Wilson, Anthony, Lucchetta, Luca, Kubicki, Mark, Cronhjort, Maria, Cioccari, Luca, Peck, Lea, Young, Helen, Eastwood, Glenn M, Martensson, Johan, Glassford, Neil J, and Bellomo, Rinaldo

Published
2020

15. Heterogeneity of treatment effect of higher dose dexamethasone by geographic region (Europe vs. India) in patients with COVID-19 and severe hypoxemia – a post hoc evaluation of the COVID STEROID 2 trial

Author

Tirupakuzhi Vijayaraghavan, Bharath Kumar, primary, Granholm, Anders, additional, Myatra, Sheila N., additional, Jha, Vivekanand, additional, Hammond, Naomi, additional, Micallef, Sharon, additional, Munch, Marie Warrer, additional, Kjær, Maj-Brit N., additional, Møller, Morten Hylander, additional, Lange, Theis, additional, Perner, Anders, additional, Venkatesh, Balasubramanian, additional, Munch, Marie W., additional, Tirupakuzhi Vijayaraghavan, Bharath Kumar, additional, Saseedharan, Sanjith, additional, Benfield, Thomas, additional, Wahlin, Rebecka R., additional, Rasmussen, Bodil S., additional, Andreasen, Anne Sofie, additional, Poulsen, Lone M., additional, Cioccari, Luca, additional, Khan, Mohd S., additional, Kapadia, Farhad, additional, Divatia, Jigeeshu V., additional, Brøchner, Anne C., additional, Bestle, Morten H., additional, Helleberg, Marie, additional, Michelsen, Jens, additional, Padmanaban, Ajay, additional, Bose, Neeta, additional, Møller, Anders, additional, Borawake, Kapil, additional, Kristiansen, Klaus T., additional, Shukla, Urvi, additional, Chew, Michelle S., additional, Dixit, Subhal, additional, Ulrik, Charlotte S., additional, Amin, Pravin R., additional, Chawla, Rajesh, additional, Wamberg, Christian A., additional, Shah, Mehul S., additional, Darfelt, Iben S., additional, Jørgensen, Vibeke L., additional, Smitt, Margit, additional, Møller, Morten H., additional, Meyhoff, Tine S., additional, Vesterlund, Gitte K., additional, Hammond, Naomi E., additional, Bassi, Abhinav, additional, John, Oommen, additional, Jha, Anubhuti, additional, Cronhjort, Maria, additional, Jakob, Stephan M., additional, Gluud, Christian, additional, Kadam, Vaijayanti, additional, Marcussen, Klaus V., additional, Hollenberg, Jacob, additional, Hedman, Anders, additional, Nielsen, Henrik, additional, Schjørring, Olav L., additional, Jensen, Marie Q., additional, Leistner, Jens W., additional, Jonassen, Trine B., additional, Kristensen, Camilla M., additional, Clapp, Esben C., additional, Hjortsø, Carl J.S., additional, Jensen, Thomas S., additional, Halstad, Liv S., additional, Bak, Emilie R.B., additional, Zaabalawi, Reem, additional, Metcalf-Clausen, Matias, additional, Abdi, Suhayb, additional, Hatley, Emma V., additional, Aksnes, Tobias S., additional, Gleipner-Andersen, Emil, additional, Alarcón, A.Felix, additional, Yamin, Gabriel, additional, Heymowski, Adam, additional, Berggren, Anton, additional, la Cour, Kirstine, additional, Weihe, Sarah, additional, Pind, Alison H., additional, and Engstrøm, Janus, additional

Published
2023
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20. Continual hemodynamic monitoring with a single-use transesophageal echocardiography probe in critically ill patients with shock: a randomized controlled clinical trial

Author

Merz, Tobias M., Cioccari, Luca, Frey, Pascal M., Bloch, Andreas, Berger, David, Zante, Bjoern, and Jakob, Stephan M.

Subjects
Mortality, Shock -- Health aspects, Echocardiography -- Health aspects, Patient monitoring equipment -- Health aspects, Clinical trials -- Health aspects, Health care industry
Abstract

Purpose Mortality in circulatory shock is high. Enhanced resolution of shock may improve outcomes. We aim to determine whether adding hemodynamic monitoring with continual transesophageal echocardiography (hTEE) to usual care accelerates resolution of hemodynamic instability. Methods 550 patients with circulatory shock were randomly assigned to four groups stratified using hTEE (hTEE vs usual care) and assessment frequency (minimum every 4 h vs 8 h). Primary outcome was time to resolution of hemodynamic instability, analyzed as intention-to-treat (ITT) analysis at day 6 and in a predefined secondary analysis at days 3 and 28. Results Of 550 randomized patients, 271 with hTEE and 274 patients with usual care were eligible and included in the ITT analysis. Time to resolution of hemodynamic instability did not differ within the first 6 days [hTEE vs usual care adjusted sub-hazard ratio (SHR) 1.20, 95% confidence interval (CI) 0.98-1.46, p = 0.067]. Time to resolution of hemodynamic instability during the 72 h of hTEE monitoring was shorter in patients with TEE (hTEE vs usual care SHR 1.26, 95% CI 1.02-1.55, p = 0.034). Assessment frequency had no influence. Time to resolution of clinical signs of hypoperfusion, duration of organ support, length of stay and mortality in the intensive care unit and hospital, and mortality at 28 days did not differ between groups. Conclusions In critically ill patients with shock, hTEE monitoring or hemodynamic assessment frequency did not influence resolution of hemodynamic instability or mortality within the first 6 days. Trial registration and statistical analysis plan ClinicalTrials.gov Identifier: NCT02048566., Author(s): Tobias M. Merz [sup.1], Luca Cioccari [sup.1], Pascal M. Frey [sup.2], Andreas Bloch [sup.1], David Berger [sup.1], Bjoern Zante [sup.1], Stephan M. Jakob [sup.1], Jukka Takala [sup.1] Author Affiliations: [...]

Published
2019
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21. Small volume resuscitation with 20% albumin in intensive care: physiological effects

Author

Mårtensson, Johan, Bihari, Shailesh, Bannard-Smith, Jonathan, Glassford, Neil J., Lloyd-Donald, Patryck, Cioccari, Luca, and Luethi, Nora

Subjects
Medical colleges -- Physiological aspects -- Research, Albumin -- Research -- Physiological aspects, Hospital patients -- Physiological aspects -- Research, Health care industry
Abstract

Purpose We set out to assess the resuscitation fluid requirements and physiological and clinical responses of intensive care unit (ICU) patients resuscitated with 20% albumin versus 4-5% albumin. Methods We performed a randomised controlled trial in 321 adult patients requiring fluid resuscitation within 48 h of admission to three ICUs in Australia and the UK. Results The cumulative volume of resuscitation fluid at 48 h (primary outcome) was lower in the 20% albumin group than in the 4-5% albumin group [median difference - 600 ml, 95% confidence interval (CI) - 800 to - 400; P < 0.001]. The 20% albumin group had lower cumulative fluid balance at 48 h (mean difference - 576 ml, 95% CI - 1033 to - 119; P = 0.01). Peak albumin levels were higher but sodium and chloride levels lower in the 20% albumin group. Median (interquartile range) duration of mechanical ventilation was 12.0 h (7.6, 33.1) in the 20% albumin group and 15.3 h (7.7, 58.1) in the 4-5% albumin group (P = 0.13); the proportion of patients commenced on renal replacement therapy after randomization was 3.3% and 4.2% (P = 0.67), respectively, and the proportion discharged alive from ICU was 97.4% and 91.1% (P = 0.02). Conclusions Resuscitation with 20% albumin decreased resuscitation fluid requirements, minimized positive early fluid balance and was not associated with any evidence of harm compared with 4-5% albumin. These findings support the safety of further exploration of resuscitation with 20% albumin in larger randomised trials. Trial registration http://www.anzctr.org.au. Identifier ACTRN12615000349549., Author(s): Johan Mårtensson [sup.1] [sup.2] [sup.13], Shailesh Bihari [sup.3] [sup.4], Jonathan Bannard-Smith [sup.5], Neil J. Glassford [sup.1], Patryck Lloyd-Donald [sup.1], Luca Cioccari [sup.1] [sup.6], Nora Luethi [sup.1], Aiko Tanaka [sup.1] [...]

Published
2018
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27. Additional file 1 of Sodium glucose co-transporter-2 inhibitors in intensive care unit patients with type 2 diabetes: a pilot case control study

Author

Mårtensson, Johan, Cutuli, Salvatore Lucio, Osawa, Eduardo A., Yanase, Fumitaka, Toh, Lisa, Cioccari, Luca, Luethi, Nora, Maeda, Akinori, and Bellomo, Rinaldo

Abstract

Additional file 1: Table S1. Pre-ICU diabetes therapy in treatment group patients. Table S2. Urine culture findings in the control group and treatment group, respectively. Fig. S1. Liberal protocol for blood glucose management of patients with diabetes at the Austin Hospital Intensive Care Unit. Fig. S2. Distribution of blood ketone measurements with respect to sample time in control group patients and treatment group patients.

Published
2023
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29. Heterogeneous treatment effects of dexamethasone 12 mg versus 6 mg in patients with COVID ‐19 and severe hypoxaemia—Post hoc exploratory analyses of the COVID STEROID 2 trial

Author

Granholm, Anders, primary, Munch, Marie Warrer, additional, Andersen‐Ranberg, Nina, additional, Myatra, Sheila Nainan, additional, Vijayaraghavan, Bharath Kumar Tirupakuzhi, additional, Venkatesh, Balasubramanian, additional, Jha, Vivekanand, additional, Wahlin, Rebecka Rubenson, additional, Jakob, Stephan M., additional, Cioccari, Luca, additional, Møller, Morten Hylander, additional, and Perner, Anders, additional

Published
2022
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34. Heterogenous treatment effects of dexamethasone 12 mg vs. 6 mg in patients with COVID-19 and severe hypoxaemia - post hoc exploratory analyses of the COVID STEROID 2 trial

Author

Granholm, Anders, Munch, Marie Warrer, Andersen-Ranberg, Nina, Myatra, Sheila Nainan, Vijayaraghavan, Bharath Kumar Tirupakuzhi, Venkatesh, Balasubramanian, Jha, Vivekanand, Rubenson, Rebecka Wahlin, Jakob, Stephan M, Cioccari, Luca, Møller, Morten Hylander, and Perner, Anders

Subjects
610 Medizin und Gesundheit
Abstract

BACKGROUND Corticosteroids improve outcomes in patients with severe COVID-19. In the COVID STEROID 2 randomised clinical trial, we found high probabilities of benefit with dexamethasone 12 mg vs. 6 mg daily. While no statistically significant heterogeneity in treatment effects (HTE) was found in the conventional, dichotomous subgroup analyses, these analyses have limitations, and HTE could still exist. METHODS We assessed whether HTE were present for days alive without life support and mortality at day 90 in the trial according to baseline age, weight, number of comorbidities, category of respiratory failure (type of respiratory support system and oxygen requirements), and predicted risk of mortality using an internal prediction model. We used flexible models for continuous variables and logistic regressions for categorical variables without dichotomisation of the baseline variables of interest. HTE was assessed both visually and with P- and S-values from likelihood ratio tests. RESULTS There was no strong evidence for substantial HTE on either outcome according to any of the baseline variables assessed with all P-values >0.37 (and all S-values

Published
2022
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35. Heterogeneous treatment effects of dexamethasone 12 mg versus 6 mg in patients with COVID‐19 and severe hypoxaemia—Post hoc exploratory analyses of the COVID STEROID 2 trial.

Author

Granholm, Anders, Munch, Marie Warrer, Andersen‐Ranberg, Nina, Myatra, Sheila Nainan, Vijayaraghavan, Bharath Kumar Tirupakuzhi, Venkatesh, Balasubramanian, Jha, Vivekanand, Wahlin, Rebecka Rubenson, Jakob, Stephan M., Cioccari, Luca, Møller, Morten Hylander, and Perner, Anders

Subjects
COVID-19, LIKELIHOOD ratio tests, DEXAMETHASONE, TREATMENT effectiveness, RESPIRATORY organs
Abstract

Background: Corticosteroids improve outcomes in patients with severe COVID‐19. In the COVID STEROID 2 randomised clinical trial, we found high probabilities of benefit with dexamethasone 12 versus 6 mg daily. While no statistically significant heterogeneity in treatment effects (HTE) was found in the conventional, dichotomous subgroup analyses, these analyses have limitations, and HTE could still exist. Methods: We assessed whether HTE was present for days alive without life support and mortality at Day 90 in the trial according to baseline age, weight, number of comorbidities, category of respiratory failure (type of respiratory support system and oxygen requirements) and predicted risk of mortality using an internal prediction model. We used flexible models for continuous variables and logistic regressions for categorical variables without dichotomisation of the baseline variables of interest. HTE was assessed both visually and with p and S values from likelihood ratio tests. Results: There was no strong evidence for substantial HTE on either outcome according to any of the baseline variables assessed with all p values >.37 (and all S values <1.43) in the planned analyses and no convincingly strong visual indications of HTE. Conclusions: We found no strong evidence for HTE with 12 versus 6 mg dexamethasone daily on days alive without life support or mortality at Day 90 in patients with COVID‐19 and severe hypoxaemia, although these results cannot rule out HTE either. [ABSTRACT FROM AUTHOR]

Published
2023
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37. Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia:The COVID STEROID 2 Randomized Trial

Author

Munch, Marie W, Myatra, Sheila N, Vijayaraghavan, Bharath Kumar Tirupakuzhi, Saseedharan, Sanjith, Benfield, Thomas, Wahlin, Rebecka R, Rasmussen, Bodil S, Andreasen, Anne Sofie, Poulsen, Lone M, Cioccari, Luca, Khan, Mohd S, Kapadia, Farhad, Divatia, Jigeeshu V, Br��chner, Anne C, Bestle, Morten H, Helleberg, Marie, Michelsen, Jens, Padmanaban, Ajay, Bose, Neeta, M��ller, Anders, Borawake, Kapil, Kristiansen, Klaus T, Shukla, Urvi, Chew, Michelle S, Dixit, Subhal, Ulrik, Charlotte S, Amin, Pravin R, Chawla, Rajesh, Wamberg, Christian A, Shah, Mehul S, Darfelt, Iben S, J��rgensen, Vibeke L, Smitt, Margit, Granholm, Anders, Kj��r, Maj-Brit N, M��ller, Morten H, Meyhoff, Tine S, Vesterlund, Gitte K, Hammond, Naomi E, Micallef, Sharon, Bassi, Abhinav, John, Oommen, Jha, Anubhuti, Cronhjort, Maria, Jakob, Stephan M, Gluud, Christian, Lange, Theis, Kadam, Vaijayanti, Marcussen, Klaus V, Hollenberg, Jacob, Hedman, Anders, Nielsen, Henrik, Schj��rring, Olav L, Jensen, Marie Q, Leistner, Jens W, Jonassen, Trine B, Kristensen, Camilla M, Clapp, Esben C, Hjorts��, Carl J S, Jensen, Thomas S, Halstad, Liv S, Bak, Emilie R B, Zaabalawi, Reem, Metcalf-Clausen, Matias, Abdi, Suhayb, Hatley, Emma V, Aksnes, Tobias S, Gleipner-Andersen, Emil, Alarc��n, Arif F, Yamin, Gabriel, Heymowski, Adam, Berggren, Anton, La Cour, Kirstine, Weihe, Sarah, Pind, Alison H, Engstr��m, Janus, Jha, Vivekanand, Venkatesh, Balasubramanian, and Perner, Anders

Subjects
Dexamethasone/administration & dosage, Male, Mycoses/etiology, medicine.medical_treatment, Dexamethasone, Hypoxemia, law.invention, Randomized controlled trial, law, medicine, Shock, Septic/etiology, Humans, Single-Blind Method, Hypoxia, 610 Medicine & health, Glucocorticoids, Aged, Mechanical ventilation, Dose-Response Relationship, Drug, Septic shock, business.industry, Hypoxia/etiology, COVID-19, Glucocorticoids/administration & dosage, General Medicine, Middle Aged, medicine.disease, Shock, Septic, Respiration, Artificial, COVID-19 Drug Treatment, Life Support Care, Dose–response relationship, Mycoses, Relative risk, Anesthesia, Life support, COVID-19/complications, Female, medicine.symptom, business, medicine.drug
Abstract

Importance A daily dose with 6 mg of dexamethasone is recommended for up to 10 days in patients with severe and critical COVID-19, but a higher dose may benefit those with more severe disease. Objective To assess the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia. Design, Setting, and Participants A multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation. End of 90-day follow-up was on August 19, 2021. Interventions Patients were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n���=���503) or 6 mg/d of intravenous dexamethasone (n���=���497) for up to 10 days. Main Outcomes and Measures The primary outcome was the number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days and was adjusted for stratification variables. Of the 8 prespecified secondary outcomes, 5 are included in this analysis (the number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality at 28 days and at 90 days, and ���1 serious adverse reactions at 28 days). Results Of the 1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and primary outcome data were available for 971 (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group). The median number of days alive without life support was 22.0 days (IQR, 6.0-28.0 days) in the 12 mg of dexamethasone group and 20.5 days (IQR, 4.0-28.0 days) in the 6 mg of dexamethasone group (adjusted mean difference, 1.3 days [95% CI, 0-2.6 days]; P���=���.07). Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group (adjusted relative risk, 0.86 [99% CI, 0.68-1.08]). Mortality at 90 days was 32.0% in the 12 mg of dexamethasone group vs 37.7% in the 6 mg of dexamethasone group (adjusted relative risk, 0.87 [99% CI, 0.70-1.07]). Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83 [99% CI, 0.54-1.29]). Conclusions and Relevance Among patients with COVID-19 and severe hypoxemia, 12 mg/d of dexamethasone compared with 6 mg/d of dexamethasone did not result in statistically significantly more days alive without life support at 28 days. However, the trial may have been underpowered to identify a significant difference. Trial Registration ClinicalTrials.gov Identifier: NCT04509973 and ctri.nic.in Identifier: CTRI/2020/10/028731.

Published
2021

38. Dexamethasone 12 mg versus 6 mg for patients with COVID-19 and severe hypoxaemia: a pre-planned, secondary Bayesian analysis of the COVID STEROID 2 trial

Author

Granholm, Anders, primary, Munch, Marie Warrer, additional, Myatra, Sheila Nainan, additional, Vijayaraghavan, Bharath Kumar Tirupakuzhi, additional, Cronhjort, Maria, additional, Wahlin, Rebecka Rubenson, additional, Jakob, Stephan M., additional, Cioccari, Luca, additional, Kjær, Maj-Brit Nørregaard, additional, Vesterlund, Gitte Kingo, additional, Meyhoff, Tine Sylvest, additional, Helleberg, Marie, additional, Møller, Morten Hylander, additional, Benfield, Thomas, additional, Venkatesh, Balasubramanian, additional, Hammond, Naomi E., additional, Micallef, Sharon, additional, Bassi, Abhinav, additional, John, Oommen, additional, Jha, Vivekanand, additional, Kristiansen, Klaus Tjelle, additional, Ulrik, Charlotte Suppli, additional, Jørgensen, Vibeke Lind, additional, Smitt, Margit, additional, Bestle, Morten H., additional, Andreasen, Anne Sofie, additional, Poulsen, Lone Musaeus, additional, Rasmussen, Bodil Steen, additional, Brøchner, Anne Craveiro, additional, Strøm, Thomas, additional, Møller, Anders, additional, Khan, Mohd Saif, additional, Padmanaban, Ajay, additional, Divatia, Jigeeshu Vasishtha, additional, Saseedharan, Sanjith, additional, Borawake, Kapil, additional, Kapadia, Farhad, additional, Dixit, Subhal, additional, Chawla, Rajesh, additional, Shukla, Urvi, additional, Amin, Pravin, additional, Chew, Michelle S., additional, Wamberg, Christian Aage, additional, Gluud, Christian, additional, Lange, Theis, additional, and Perner, Anders, additional

Published
2021
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40. Low‐dose hydrocortisone in patients with COVID‐19 and severe hypoxia: The COVID STEROID randomised, placebo‐controlled trial

Author

Munch, Marie Warrer, primary, Meyhoff, Tine Sylvest, additional, Helleberg, Marie, additional, Kjær, Maj‐Brit Nørregaard, additional, Granholm, Anders, additional, Hjortsø, Carl Johan Steensen, additional, Jensen, Thomas Steen, additional, Møller, Morten Hylander, additional, Hjortrup, Peter Buhl, additional, Wetterslev, Mik, additional, Vesterlund, Gitte Kingo, additional, Russell, Lene, additional, Jørgensen, Vibeke Lind, additional, Kristiansen, Klaus Tjelle, additional, Benfield, Thomas, additional, Ulrik, Charlotte Suppli, additional, Andreasen, Anne Sofie, additional, Bestle, Morten Heiberg, additional, Poulsen, Lone Musaeus, additional, Hildebrandt, Thomas, additional, Knudsen, Lene Surland, additional, Møller, Anders, additional, Sølling, Christoffer Grant, additional, Brøchner, Anne Craveiro, additional, Rasmussen, Bodil Steen, additional, Nielsen, Henrik, additional, Christensen, Steffen, additional, Strøm, Thomas, additional, Cronhjort, Maria, additional, Wahlin, Rebecka Rubenson, additional, Jakob, Stephan M., additional, Cioccari, Luca, additional, Venkatesh, Balasubramanian, additional, Hammond, Naomi, additional, Jha, Vivekanand, additional, Myatra, Sheila Nainan, additional, Jensen, Marie Qvist, additional, Leistner, Jens Wolfgang, additional, Mikkelsen, Vibe Sommer, additional, Svenningsen, Jens S., additional, Laursen, Signe Bjørn, additional, Hatley, Emma Victoria, additional, Kristensen, Camilla Meno, additional, Al‐Alak, Ali, additional, Clapp, Esben, additional, Jonassen, Trine Bak, additional, Bjerregaard, Caroline Løkke, additional, Østerby, Niels Christian Haubjerg, additional, Jespersen, Mette Mindedahl, additional, Abou‐Kassem, Dalia, additional, Lassen, Mathilde Languille, additional, Zaabalawi, Reem, additional, Daoud, Mohammed Mahmoud, additional, Abdi, Suhayb, additional, Meier, Nick, additional, la Cour, Kirstine, additional, Derby, Cecilie Bauer, additional, Damlund, Birka Ravnholt, additional, Laigaard, Jens, additional, Andersen, Lene Lund, additional, Mikkelsen, Johan, additional, Jensen, Jeppe Lundholm Stadarfeld, additional, Rasmussen, Anders Hørby, additional, Arnerlöv, Emil, additional, Lykke, Mathilde, additional, Holst‐Hansen, Mikkel Zacharias Bystrup, additional, Tøstesen, Boris Wied, additional, Schwab, Janne, additional, Madsen, Emilie Kabel, additional, Gluud, Christian, additional, Lange, Theis, additional, and Perner, Anders, additional

Published
2021
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43. sj-pdf-1-prf-10.1177_02676591211012204 – Supplemental material for The hemodynamic effects of warm versus room-temperature crystalloid fluid bolus therapy in post-cardiac surgery patients

Author

Bitker, Laurent, Cutuli, Salvatore L, Fumitaka Yanase, Wilson, Anthony, Osawa, Eduardo A, Lucchetta, Luca, Cioccari, Luca, Canet, Emmanuel, Glassford, Neil, Eastwood, Glenn M, and Bellomo, Rinaldo

Subjects
FOS: Clinical medicine, Cardiology, 110323 Surgery
Abstract

Supplemental material, sj-pdf-1-prf-10.1177_02676591211012204 for The hemodynamic effects of warm versus room-temperature crystalloid fluid bolus therapy in post-cardiac surgery patients by Laurent Bitker, Salvatore L Cutuli, Fumitaka Yanase, Anthony Wilson, Eduardo A Osawa, Luca Lucchetta, Luca Cioccari, Emmanuel Canet, Neil Glassford, Glenn M Eastwood and Rinaldo Bellomo in Perfusion

Published
2021
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44. The hemodynamic effects of warm versus room-temperature crystalloid fluid bolus therapy in post-cardiac surgery patients

Author

Bitker, Laurent, Cutuli, Salvatore L, Yanase, Fumitaka, Wilson, Anthony, Osawa, Eduardo A, Lucchetta, Luca, Cioccari, Luca, Canet, Emmanuel, Glassford, Neil, Eastwood, Glenn M, and Bellomo, Rinaldo

Subjects
610 Medicine & health
Abstract

INTRODUCTION The contribution of fluid temperature to the effect of crystalloid fluid bolus therapy (FBT) in post-cardiac surgery patients is unknown. We evaluated the hemodynamic effects of FBT with fluid warmed to 40°C (warm FBT) versus room-temperature fluid. METHODS In this single centre prospective before-and-after study, we evaluated the effects of 500 ml of warm versus room-temperature compound sodium lactate administered over 15% of baseline immediately after FBT and effect dissipation if the CI returned to 10% increase and dissipation as return to 0.3°C in 13 (52%) patients after room-temperature FBT versus 0 (0%) after warm FBT (p

Published
2021
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45. The hemodynamic effects of warm versus room-temperature crystalloid fluid bolus therapy in post-cardiac surgery patients.

Author

Bitker, Laurent, Cutuli, Salvatore L, Yanase, Fumitaka, Wilson, Anthony, Osawa, Eduardo A, Lucchetta, Luca, Cioccari, Luca, Canet, Emmanuel, Glassford, Neil, Eastwood, Glenn M, and Bellomo, Rinaldo

Subjects
CARDIAC surgery, PILOT projects, STATISTICAL power analysis, STATISTICS, INTENSIVE care units, TEMPERATURE, CONFIDENCE intervals, BODY temperature, MULTIVARIATE analysis, FISHER exact test, MANN Whitney U Test, REGRESSION analysis, PATIENT-centered care, ARTIFICIAL respiration, MEDICAL protocols, INDICATOR dilution, VASODILATION, BLOOD plasma substitutes, CARDIAC output, HEMODYNAMICS, DATA analysis, LONGITUDINAL method
Abstract

Introduction: The contribution of fluid temperature to the effect of crystalloid fluid bolus therapy (FBT) in post-cardiac surgery patients is unknown. We evaluated the hemodynamic effects of FBT with fluid warmed to 40°C (warm FBT) versus room-temperature fluid. Methods: In this single centre prospective before-and-after study, we evaluated the effects of 500 ml of warm versus room-temperature compound sodium lactate administered over <30 minutes, in 50 cardiac surgery patients admitted to ICU. We recorded hemodynamics continuous before and for 30 minutes after the first FBT. We defined CI responsiveness (CI-R) as an CI increase >15% of baseline immediately after FBT and effect dissipation if the CI returned to <5% of baseline and MAP responsiveness as >10% increase and dissipation as return to <3 mmHg of baseline. Results: Hypotension (56%) and low CI (40%) typically triggered FBT. Temperature decreased >0.3°C in 13 (52%) patients after room-temperature FBT versus 0 (0%) after warm FBT (p < 0.01). CI and MAP responsiveness was similar (16 [64%] versus 11 [44%], p = 0.15 and 15 [60%] versus 17 [68%], p = 0.77, respectively). Among CI responders, CI increased more with room-temperature FBT (+0.6 [IQR, 0.5–1.1] versus +0.5 [IQR, 0.4–0.6] L/min/m2, p = 0.01). However, dissipation was more common after room-temperature versus warm FBT (9/16 [56%] versus 1/11 [9%], p = 0.02). Conclusion: In postoperative cardiac surgery patients, warm FBT preserved core temperature and induced smaller but more sustained CI increases among responders. Fluid temperature appears to impact both core temperature and the duration of CI response. [ABSTRACT FROM AUTHOR]

Published
2022
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46. The hemodynamic effects of warm versus room-temperature crystalloid fluid bolus therapy in post-cardiac surgery patients

Author

Bitker, Laurent, primary, Cutuli, Salvatore L, additional, Yanase, Fumitaka, additional, Wilson, Anthony, additional, Osawa, Eduardo A, additional, Lucchetta, Luca, additional, Cioccari, Luca, additional, Canet, Emmanuel, additional, Glassford, Neil, additional, Eastwood, Glenn M, additional, and Bellomo, Rinaldo, additional

Published
2021
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47. Higher vs lower doses of dexamethasone in patients with COVID‐19 and severe hypoxia (COVID STEROID 2) trial: Protocol and statistical analysis plan

Author

Munch, MW, primary, Granholm, Anders, additional, Myatra, SN, additional, Vijayaraghavan, BKT, additional, Cronhjort, Maria, additional, Wahlin, RR, additional, Jakob, Stephan M., additional, Cioccari, Luca, additional, Kjær, MN, additional, Vesterlund, GK, additional, Meyhoff, TS, additional, Helleberg, Marie, additional, Møller, MH, additional, Benfield, Thomas, additional, Venkatesh, Balasubramanian, additional, Hammond, Naomi, additional, Micallef, Sharon, additional, Bassi, Abhinav, additional, John, Oommen, additional, Jha, Vivekanand, additional, Kristiansen, KT, additional, Ulrik, CS, additional, Jørgensen, VL, additional, Smitt, Margit, additional, Bestle, Morten H., additional, Andreasen, AS, additional, Poulsen, LM, additional, Rasmussen, BS, additional, Brøchner, AC, additional, Strøm, Thomas, additional, Møller, Anders, additional, Khan, MS, additional, Padmanaban, Ajay, additional, Divatia, JV, additional, Saseedharan, Sanjith, additional, Borawake, Kapil, additional, Kapadia, Farhad, additional, Dixit, Subhal, additional, Chawla, Rajesh, additional, Shukla, Urvi, additional, Amin, Pravin, additional, Chew, Michelle S., additional, Gluud, Christian, additional, Lange, Theis, additional, and Perner, Anders, additional

Published
2021
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48. Higher vs Lower Doses of Dexamethasone in Patients with COVID‐19 and Severe Hypoxia (COVID STEROID 2) trial: Protocol for a secondary Bayesian analysis

Author

Granholm, Anders, primary, Munch, Marie Warrer, additional, Myatra, Sheila Nainan, additional, Vijayaraghavan, Bharath Kumar Tirupakuzhi, additional, Cronhjort, Maria, additional, Wahlin, Rebecka Rubenson, additional, Jakob, Stephan M., additional, Cioccari, Luca, additional, Kjær, Maj‐Brit Nørregaard, additional, Vesterlund, Gitte Kingo, additional, Meyhoff, Tine Sylvest, additional, Helleberg, Marie, additional, Møller, Morten Hylander, additional, Benfield, Thomas, additional, Venkatesh, Balasubramanian, additional, Hammond, Naomi, additional, Micallef, Sharon, additional, Bassi, Abhinav, additional, John, Oommen, additional, Jha, Vivekanand, additional, Kristiansen, Klaus Tjelle, additional, Ulrik, Charlotte Suppli, additional, Jørgensen, Vibeke Lind, additional, Smitt, Margit, additional, Bestle, Morten H., additional, Andreasen, Anne Sofie, additional, Poulsen, Lone Musaeus, additional, Rasmussen, Bodil Steen, additional, Brøchner, Anne Craveiro, additional, Strøm, Thomas, additional, Møller, Anders, additional, Khan, Mohd Saif, additional, Padmanaban, Ajay, additional, Divatia, Jigeeshu Vasishtha, additional, Saseedharan, Sanjith, additional, Borawake, Kapil, additional, Kapadia, Farhad, additional, Dixit, Subhal, additional, Chawla, Rajesh, additional, Shukla, Urvi, additional, Amin, Pravin, additional, Chew, Michelle S., additional, Gluud, Christian, additional, Lange, Theis, additional, and Perner, Anders, additional

Published
2021
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49. Dexamethasone 12 mg Versus 6 mg for Patients With COVID-19 and Severe Hypoxia: An International, Randomised, Blinded Trial

Author

Warrer Munch, Marie, primary, Myatra, Sheila Nainan, additional, Kumar Tirupakuzhi Vijavaraghavan, Bharath, additional, Saseedharan, Sanjith, additional, Benfield, Thomas, additional, Rubenson Wahlin, Rebecka, additional, Steen Rasmussen, Bodil, additional, Andreasen, Anne Sofie, additional, M. Poulsen, Lone, additional, Cioccari, Luca, additional, Saif Khan, Mohd, additional, Kapadia, Farhad, additional, Divatia, Jigeeshu, additional, C. Brøncher, Anne, additional, H. Bestle, Morten, additional, Helleberg, Marie, additional, Michelsen, Jens, additional, Padmanaban, Ajay, additional, Bose, Neeta, additional, Møller, Anders, additional, Borawake, Kapil, additional, Tjelle Kristensen, Klaus, additional, Shukla, Urvi B., additional, Chew, Michelle S., additional, Dixit, Subhal, additional, Suppli Ulrik, Charlotte, additional, R. Amin, Pravin, additional, Chawla, Rajesh, additional, A. Wamberg, Christian, additional, S. Shah, Mehul, additional, S. Darfelt, Iben, additional, Lind Jørgensen, Vibeke, additional, Smitt, Margit, additional, Granholm, Anders, additional, N. Kjær, Maj-Brit, additional, Hylander Møller, Morten, additional, Sylvest Meyhoff, Tine, additional, Kingo Vesterlund, Gitte, additional, Hammond, Naomi, additional, Micallef, Sharon, additional, Bassi, Abhinav, additional, John, Oommen, additional, Jha, Anubhuti, additional, Cronhjort, Maria, additional, M. Jakob, Stephan, additional, Gluud, Christian, additional, Lange, Theis, additional, Kadam, Vaijayanti, additional, Vennick Marcussen, Klaus, additional, Hollenberg, Jacob, additional, Hedman, Anders, additional, Nielsen, Henrik, additional, L. Schjørring, Olav, additional, Qvist Jensen, Marie, additional, Wolfgang Leistner, Jens, additional, Bak Jonassen, Trine, additional, Meno Kristensen, Camilla, additional, Christensen Clapp, Esben, additional, Steensen Hjortsø, Carl Johan, additional, Steen Jensen, Thomas, additional, Sanggaard Halstad, Liv, additional, Rose Bak, Emilie, additional, Zabaalawi, Reem, additional, Metcalf-Clausen, Matias, additional, Abdi, Suhayb, additional, Victoria Hatley, Emma, additional, Aksnes, Tobias, additional, Gleipner-Andersen, Emil, additional, Alarcón, Arif F., additional, Yamin, Gabriel, additional, Heymowski, Adam, additional, Berggren, Anton, additional, La Cour, Kirstine, additional, Weihe, Sarah, additional, Holten Pind, Alison, additional, Engstrøm, Janus, additional, Jha, Vivekanand, additional, Venkatesh, Balasubramanian, additional, and Perner, Anders, additional

Published
2021
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50. Additional file 2 of The effect of dexmedetomidine on vasopressor requirements in patients with septic shock: a subgroup analysis of the Sedation Practice in Intensive Care Evaluation [SPICE III] Trial

Author

Cioccari, Luca, Luethi, Nora, Bailey, Michael, Shehabi, Yahya, Howe, Belinda, Messmer, Anna S., Proimos, Helena K., Peck, Leah, Young, Helen, Eastwood, Glenn M., Merz, Tobias M., Takala, Jukka, Jakob, Stephan M., and Bellomo, Rinaldo

Subjects
Data_FILES
Abstract

Additional file 2.

Published
2020
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