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1. Haloperidol for the Treatment of Delirium in ICU Patients

Author

Andersen-Ranberg, Nina C., primary, Poulsen, Lone M., additional, Perner, Anders, additional, Wetterslev, Jørn, additional, Estrup, Stine, additional, Hästbacka, Johanna, additional, Morgan, Matt, additional, Citerio, Giuseppe, additional, Caballero, Jesus, additional, Lange, Theis, additional, Kjær, Maj-Brit N., additional, Ebdrup, Bjørn H., additional, Engstrøm, Janus, additional, Olsen, Markus H., additional, Oxenbøll Collet, Marie, additional, Mortensen, Camilla B., additional, Weber, Sven-Olaf, additional, Andreasen, A. Sofie, additional, Bestle, Morten H., additional, Uslu, Bülent, additional, Scharling Pedersen, Helle, additional, Gramstrup Nielsen, Louise, additional, Toft Boesen, Hans C., additional, Jensen, Jacob V., additional, Nebrich, Lars, additional, La Cour, Kirstine, additional, Laigaard, Jens, additional, Haurum, Cecilie, additional, Olesen, Marie W., additional, Overgaard-Steensen, Christian, additional, Westergaard, Bo, additional, Brand, Björn, additional, Kingo Vesterlund, Gitte, additional, Thornberg Kyhnauv, Pernille, additional, Mikkelsen, Vibe S., additional, Hyttel-Sørensen, Simon, additional, de Haas, Inge, additional, Aagaard, Søren R., additional, Nielsen, Line O., additional, Eriksen, Anne S., additional, Rasmussen, Bodil S., additional, Brix, Helene, additional, Hildebrandt, Thomas, additional, Schønemann-Lund, Martin, additional, Fjeldsøe-Nielsen, Hans, additional, Kuivalainen, Anna-Maria, additional, and Mathiesen, Ole, additional

Published
2022
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2. Haloperidol for the Treatment of Delirium in ICU Patients

Author

Andersen-Ranberg, Nina C., Poulsen, Lone M., Perner, Anders, Wetterslev, Jørn, Estrup, Stine, Haestbacka, Johanna, Morgan, Matt, Citerio, Giuseppe, Caballero, Jesus, Lange, Theis, Kjaer, Maj-Brit N., Ebdrup, Bjorn H., Engstrom, Janus, Olsen, Markus H., Oxenboll Collet, Marie, Mortensen, Camilla B., Weber, Sven-Olaf, Andreasen, A. Sofie, Bestle, Morten H., Uslu, Buelent, Scharling Pedersen, Helle, Gramstrup Nielsen, Louise, Toft Boesen, Hans C., Jensen, Jacob V., Nebrich, Lars, La Cour, Kirstine, Laigaard, Jens, Haurum, Cecilie, Olesen, Marie W., Overgaard-Steensen, Christian, Westergaard, Bo, Brand, Bjorn A., Kingo Vesterlund, Gitte, Thornberg Kyhnauv, Pernille, Mikkelsen, Vibe S., Hyttel-Sorensen, Simon, de Haas, Inge, Aagaard, Soren R., Nielsen, Line O., Eriksen, Anne S., Rasmussen, Bodil S., Brix, Helene, Hildebrandt, Thomas, Schonemann-Lund, Martin, Fjeldsoe-Nielsen, Hans, Kuivalainen, Anna-Maria, Mathiesen, Ole, AID ICU Trial Grp, Andersen-Ranberg, Nina C., Poulsen, Lone M., Perner, Anders, Wetterslev, Jørn, Estrup, Stine, Haestbacka, Johanna, Morgan, Matt, Citerio, Giuseppe, Caballero, Jesus, Lange, Theis, Kjaer, Maj-Brit N., Ebdrup, Bjorn H., Engstrom, Janus, Olsen, Markus H., Oxenboll Collet, Marie, Mortensen, Camilla B., Weber, Sven-Olaf, Andreasen, A. Sofie, Bestle, Morten H., Uslu, Buelent, Scharling Pedersen, Helle, Gramstrup Nielsen, Louise, Toft Boesen, Hans C., Jensen, Jacob V., Nebrich, Lars, La Cour, Kirstine, Laigaard, Jens, Haurum, Cecilie, Olesen, Marie W., Overgaard-Steensen, Christian, Westergaard, Bo, Brand, Bjorn A., Kingo Vesterlund, Gitte, Thornberg Kyhnauv, Pernille, Mikkelsen, Vibe S., Hyttel-Sorensen, Simon, de Haas, Inge, Aagaard, Soren R., Nielsen, Line O., Eriksen, Anne S., Rasmussen, Bodil S., Brix, Helene, Hildebrandt, Thomas, Schonemann-Lund, Martin, Fjeldsoe-Nielsen, Hans, Kuivalainen, Anna-Maria, Mathiesen, Ole, and AID ICU Trial Grp

Abstract

BACKGROUND Haloperidol is frequently used to treat delirium in patients in the intensive care unit (ICU), but evidence of its effect is limited. METHODS In this multicenter, blinded, placebo-controlled trial, we randomly assigned adult patients with delirium who had been admitted to the ICU for an acute condition to receive intravenous haloperidol (2.5 mg 3 times daily plus 2.5 mg as needed up to a total maximum daily dose of 20 mg) or placebo. Haloperidol or placebo was administered in the ICU for as long as delirium continued and as needed for recurrences. The primary outcome was the number of days alive and out of the hospital at 90 days after randomization. RESULTS A total of 1000 patients underwent randomization; 510 were assigned to the haloperidol group and 490 to the placebo group. Among these patients, 987 (98.7%) were included in the final analyses (501 in the haloperidol group and 486 in the placebo group). Primary outcome data were available for 963 patients (97.6%). At 90 days, the mean number of days alive and out of the hospital was 35.8 (95% confidence interval [CI], 32.9 to 38.6) in the haloperidol group and 32.9 (95% CI, 29.9 to 35.8) in the placebo group, with an adjusted mean difference of 2.9 days (95% CI, -1.2 to 7.0) (P=0.22). Mortality at 90 days was 36.3% in the haloperidol group and 43.3% in the placebo group (adjusted absolute difference, -6.9 percentage points [95% CI, -13.0 to -0.6]). Serious adverse reactions occurred in 11 patients in the haloperidol group and in 9 patients in the placebo group. CONCLUSIONS Among patients in the ICU with delirium, treatment with haloperidol did not lead to a significantly greater number of days alive and out of the hospital at 90 days than placebo.

Published
2022

3. Haloperidol for the Treatment of Delirium in ICU Patients

Author

Andersen-Ranberg, N, Poulsen, L, Perner, A, Wetterslev, J, Estrup, S, Hästbacka, J, Morgan, M, Citerio, G, Caballero, J, Lange, T, Kjær, M, Ebdrup, B, Engstrøm, J, Olsen, M, Oxenbøll Collet, M, Mortensen, C, Weber, S, Andreasen, A, Bestle, M, Uslu, B, Scharling Pedersen, H, Gramstrup Nielsen, L, Toft Boesen, H, Jensen, J, Nebrich, L, La Cour, K, Laigaard, J, Haurum, C, Olesen, M, Overgaard-Steensen, C, Westergaard, B, Brand, B, Kingo Vesterlund, G, Thornberg Kyhnauv, P, Mikkelsen, V, Hyttel-Sørensen, S, de Haas, I, Aagaard, S, Nielsen, L, Eriksen, A, Rasmussen, B, Brix, H, Hildebrandt, T, Schønemann-Lund, M, Fjeldsøe-Nielsen, H, Kuivalainen, A, Mathiesen, O, Andersen-Ranberg, Nina C, Poulsen, Lone M, Perner, Anders, Wetterslev, Jørn, Estrup, Stine, Hästbacka, Johanna, Morgan, Matt, Citerio, Giuseppe, Caballero, Jesus, Lange, Theis, Kjær, Maj-Brit N, Ebdrup, Bjørn H, Engstrøm, Janus, Olsen, Markus H, Oxenbøll Collet, Marie, Mortensen, Camilla B, Weber, Sven-Olaf, Andreasen, A Sofie, Bestle, Morten H, Uslu, Bülent, Scharling Pedersen, Helle, Gramstrup Nielsen, Louise, Toft Boesen, Hans C, Jensen, Jacob V, Nebrich, Lars, La Cour, Kirstine, Laigaard, Jens, Haurum, Cecilie, Olesen, Marie W, Overgaard-Steensen, Christian, Westergaard, Bo, Brand, Björn, Kingo Vesterlund, Gitte, Thornberg Kyhnauv, Pernille, Mikkelsen, Vibe S, Hyttel-Sørensen, Simon, de Haas, Inge, Aagaard, Søren R, Nielsen, Line O, Eriksen, Anne S, Rasmussen, Bodil S, Brix, Helene, Hildebrandt, Thomas, Schønemann-Lund, Martin, Fjeldsøe-Nielsen, Hans, Kuivalainen, Anna-Maria, Mathiesen, Ole, Andersen-Ranberg, N, Poulsen, L, Perner, A, Wetterslev, J, Estrup, S, Hästbacka, J, Morgan, M, Citerio, G, Caballero, J, Lange, T, Kjær, M, Ebdrup, B, Engstrøm, J, Olsen, M, Oxenbøll Collet, M, Mortensen, C, Weber, S, Andreasen, A, Bestle, M, Uslu, B, Scharling Pedersen, H, Gramstrup Nielsen, L, Toft Boesen, H, Jensen, J, Nebrich, L, La Cour, K, Laigaard, J, Haurum, C, Olesen, M, Overgaard-Steensen, C, Westergaard, B, Brand, B, Kingo Vesterlund, G, Thornberg Kyhnauv, P, Mikkelsen, V, Hyttel-Sørensen, S, de Haas, I, Aagaard, S, Nielsen, L, Eriksen, A, Rasmussen, B, Brix, H, Hildebrandt, T, Schønemann-Lund, M, Fjeldsøe-Nielsen, H, Kuivalainen, A, Mathiesen, O, Andersen-Ranberg, Nina C, Poulsen, Lone M, Perner, Anders, Wetterslev, Jørn, Estrup, Stine, Hästbacka, Johanna, Morgan, Matt, Citerio, Giuseppe, Caballero, Jesus, Lange, Theis, Kjær, Maj-Brit N, Ebdrup, Bjørn H, Engstrøm, Janus, Olsen, Markus H, Oxenbøll Collet, Marie, Mortensen, Camilla B, Weber, Sven-Olaf, Andreasen, A Sofie, Bestle, Morten H, Uslu, Bülent, Scharling Pedersen, Helle, Gramstrup Nielsen, Louise, Toft Boesen, Hans C, Jensen, Jacob V, Nebrich, Lars, La Cour, Kirstine, Laigaard, Jens, Haurum, Cecilie, Olesen, Marie W, Overgaard-Steensen, Christian, Westergaard, Bo, Brand, Björn, Kingo Vesterlund, Gitte, Thornberg Kyhnauv, Pernille, Mikkelsen, Vibe S, Hyttel-Sørensen, Simon, de Haas, Inge, Aagaard, Søren R, Nielsen, Line O, Eriksen, Anne S, Rasmussen, Bodil S, Brix, Helene, Hildebrandt, Thomas, Schønemann-Lund, Martin, Fjeldsøe-Nielsen, Hans, Kuivalainen, Anna-Maria, and Mathiesen, Ole

Abstract

Background Haloperidol is frequently used to treat delirium in patients in the intensive care unit (ICU), but evidence of its effect is limited. Methods In this multicenter, blinded, placebo-controlled trial, we randomly assigned adult patients with delirium who had been admitted to the ICU for an acute condition to receive intravenous haloperidol (2.5 mg 3 times daily plus 2.5 mg as needed up to a total maximum daily dose of 20 mg) or placebo. Haloperidol or placebo was administered in the ICU for as long as delirium continued and as needed for recurrences. The primary outcome was the number of days alive and out of the hospital at 90 days after randomization. Results A total of 1000 patients underwent randomization; 510 were assigned to the haloperidol group and 490 to the placebo group. Among these patients, 987 (98.7%) were included in the final analyses (501 in the haloperidol group and 486 in the placebo group). Primary outcome data were available for 963 patients (97.6%). At 90 days, the mean number of days alive and out of the hospital was 35.8 (95% confidence interval [CI], 32.9 to 38.6) in the haloperidol group and 32.9 (95% CI, 29.9 to 35.8) in the placebo group, with an adjusted mean difference of 2.9 days (95% CI, -1.2 to 7.0) (P=0.22). Mortality at 90 days was 36.3% in the haloperidol group and 43.3% in the placebo group (adjusted absolute difference, -6.9 percentage points [95% CI, -13.0 to -0.6]). Serious adverse reactions occurred in 11 patients in the haloperidol group and in 9 patients in the placebo group. Conclusions Among patients in the ICU with delirium, treatment with haloperidol did not lead to a significantly greater number of days alive and out of the hospital at 90 days than placebo.

Published
2022

4. COVID‐19 versus influenza A/B supeRInfectionS in the IntenSive care unit (CRISIS): Protocol for a Danish nationwide cohort study

Author

Mikkelsen, Vibe S., primary, Helleberg, Marie, additional, Haase, Nicolai, additional, Møller, Morten H., additional, Granholm, Anders, additional, Storgaard, Merete, additional, Jonsson, Andreas B., additional, Schønning, Kristian, additional, Reiter, Nanna, additional, Sigurðsson, Sigurður Þór, additional, Voldstedlund, Marianne, additional, Christensen, Steffen, additional, and Perner, Anders, additional

Published
2021
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5. COVID-19 versus influenza A/B supeRInfectionS in the IntenSive care unit (CRISIS):Protocol for a Danish nationwide cohort study

Author

Mikkelsen, Vibe S., Helleberg, Marie, Haase, Nicolai, Møller, Morten H., Granholm, Anders, Storgaard, Merete, Jonsson, Andreas B., Schønning, Kristian, Reiter, Nanna, Sigurðsson, Sigurður Þór, Voldstedlund, Marianne, Christensen, Steffen, Perner, Anders, Mikkelsen, Vibe S., Helleberg, Marie, Haase, Nicolai, Møller, Morten H., Granholm, Anders, Storgaard, Merete, Jonsson, Andreas B., Schønning, Kristian, Reiter, Nanna, Sigurðsson, Sigurður Þór, Voldstedlund, Marianne, Christensen, Steffen, and Perner, Anders

Abstract

Background: Superinfection following viral infection is a known complication, which may lead to longer hospitalisation and worse outcome. Empirical antibiotic therapy may prevent bacterial superinfections, but may also lead to overuse, adverse effects and development of resistant pathogens. Knowledge about the incidence of superinfections in intensive care unit (ICU) patients with severe Coronavirus Disease 2019 (COVID-19) is limited. Methods: We will conduct a nationwide cohort study comparing the incidence of superinfections in patients with severe COVID-19 admitted to the ICU compared with ICU patients with influenza A/B in Denmark. We will include approximately 1000 patients in each group from the time period of 1 October 2014 to 30 April 2019 and from 10 March 2020 to 1 March 2021 for patients with influenza and COVID-19, respectively. The primary outcome is any superinfection within 90 days of admission to the ICU. We will use logistic regression analysis comparing COVID-19 with influenza A/B after adjustment for relevant predefined confounders. Secondarily, we will use unadjusted and adjusted logistic regression analyses to assess six potential risk factors (sex, age, cancer [including haematological], immunosuppression and use of life support on day 1 in the ICU) for superinfections and compare outcomes in patients with COVID-19 with/without superinfections, and present descriptive data regarding the superinfections. Conclusion: This study will provide important knowledge about superinfections in ICU patients with severe COVID-19.

Published
2021

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