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2. Acute respiratory distress syndrome subphenotypes and differential response to simvastatin: secondary analysis of a randomised controlled trial

Author

Johnston, Andrew J, Paikray, Archana, Yates, Cat, Polgarova, Petra, Price, Esther, McInerney, Amy, Zamoscik, Katarzyna, Dempsey, Ged, Seasman, Colette, Gilfeather, Lynn, Hemmings, Noel, O'Kane, Sinead, Johnston, Paul, Pokorny, Lukas, Nutt, Chris, O'Neill, Orla, Prashast, Prashast, Smalley, Chris, Jacob, Reni, O'Rourke, James, Sultan, Syed Farjad, Schilling, Carole, Perkins, Gavin D, Melody, Teresa, Couper, Keith, Daniels, Ron, Gao, Fang, Hull, Julian, Gould, Timothy, Thomas, Matthew, Sweet, Katie, Breen, Dorothy, Neau, Emer, Peel, Willis J, Jardine, Catherine, Jefferson, Paul, Wright, Stephen E, Harris, Kayla, Hierons, Sarah, Laffey, John, McInerney, Veronica, Camporota, Luigi, Lei, Katie, Kaul, Sundeep, Chibvuri, Molly, Gratrix, Andrew, Bennett, Rachael, Martinson, Victoria, Sleight, Lisa, Smith, Neil, Hopkins, Philip A, Hadfield, Daniel, Casboult, Sarah, Wade-Smith, Fiona, Dawson, Julie, Mellis, Clare, Harris, Clair, Parsons, Georgina, Helyar, Sinead, Bodenham, Andrew R, Elliot, Stuart, Beardow, Zoe, Birch, Sian, Marsh, Brian, Martin, Teresa, Dhrampal, Akesh, Rosbergen, Melissa, Webb, Stephen, Bottrill, Fiona, Reschreiter, Henrik, Barcraft-Barnes, Helena, Camsooksai, Julie, Johnston, Andrew, Clarkson, Aisling, Bentley, Conor, Cooper, Lauren, Qui, Yongyan, Mitchell, Natalie, Carrera, Ronald, Whitehouse, Arlo, Danbury, Christopher M, Jacques, Nicola, Brown, Abby, Rogerson, David, Morris, Craig, Walsh, Timothy, Gillies, Mike, Price, Grant, Kefala, Kallirroi, Young, Neil, Hope, David, McCulloch, Corrienne, Antonelli, Jean, Ramsay, Pam, Everingham, Kirsty, Boardman, Louise, Dawson, Heidi, Pollock, Fiona, Thompson, Joanne, Welters, Ingeborg D, Poole, Lee, Hampshire, Peter, Hall, Alison, Williams, Karen, Walker, Anna, Youds, Laura, Hendry, Samantha, Waugh, Victoria, Patrick-Heselton, Julie, Shaw, David, Chaudry, Irfan, Baldwin, Jacqueline, Drage, Stephen, Ortiz-Ruiz de Gordoa, Laura, McAuley, Daniel, Bannon, Leona, Quinn, Vanessa, McNamee, Lia, White, Griania, Cecconi, Maurizio, Mellinghoff, Johannes, Ryan, Donal, Nichol, Alistair, Agarwal, Banwari, Meale, Paula, James, Sarah, Dhadwal, Kulwant, Martin, Daniel, Walecka, Agnieszka, Ward, Stephen, Trinder, John, Hagan, Samantha, Montgomery, Janice, Leonard, Catherine, Lemon, Elizabeth, Trinick, Tom, Buddhavarapu, Murthy, Ward, Geraldine, Bassford, Christopher, Davidson, Alan, McGuigan, Kate, Benchiheub, Anissa, Hickey, Naomi, Binning, Alexander, Henderson, Steven, Wood, J A, Burtenshaw, Andrew J, Kelly, Dawn, Martin, Terry, Thrush, Jessica, Wollaston, Julie, Graystone, Stephen, Nicol, Gavin, Sellors, Gareth, Calfee, Carolyn S, Delucchi, Kevin L, Sinha, Pratik, Matthay, Michael A, Hackett, Jonathan, Shankar-Hari, Manu, McDowell, Cliona, Laffey, John G, O'Kane, Cecilia M, and McAuley, Daniel F

Published
2018
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3. Early PREdiction of sepsis using leukocyte surface biomarkers: the ExPRES-sepsis cohort study

Author

Shankar-Hari, Manu, Datta, Deepankar, Wilson, Julie, Assi, Valentina, Stephen, Jacqueline, Weir, Christopher J., Rennie, Jillian, Antonelli, Jean, Bateman, Anthony, Felton, Jennifer M., Warner, Noel, Judge, Kevin, Keenan, Jim, Wang, Alice, Burpee, Tony, Brown, Alun K., Lewis, Sion M., Mare, Tracey, Roy, Alistair I., Wright, John, Hulme, Gillian, Dimmick, Ian, Gray, Alasdair, Rossi, Adriano G., Simpson, A. John, Conway Morris, Andrew, and Walsh, Timothy S.

Published
2018
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4. Cell-surface signatures of immune dysfunction risk-stratify critically ill patients: INFECT study

Author

Conway Morris, Andrew, Datta, Deepankar, Shankar-Hari, Manu, Stephen, Jacqueline, Weir, Christopher J., Rennie, Jillian, and Antonelli, Jean

Subjects
Medical research -- Health aspects, Medicine, Experimental -- Health aspects, T cells -- Health aspects, Infection -- Care and treatment, Health care industry
Abstract

Purpose Cellular immune dysfunctions, which are common in intensive care patients, predict a number of significant complications. In order to effectively target treatments, clinically applicable measures need to be developed to detect dysfunction. The objective was to confirm the ability of cellular markers associated with immune dysfunction to stratify risk of secondary infection in critically ill patients. Methods Multi-centre, prospective observational cohort study of critically ill patients in four UK intensive care units. Serial blood samples were taken, and three cell surface markers associated with immune cell dysfunction [neutrophil CD88, monocyte human leucocyte antigen-DR (HLA-DR) and percentage of regulatory T cells (T.sub.regs)] were assayed on-site using standardized flow cytometric measures. Patients were followed up for the development of secondary infections. Results A total of 148 patients were recruited, with data available from 138. Reduced neutrophil CD88, reduced monocyte HLA-DR and elevated proportions of T.sub.regs were all associated with subsequent development of infection with odds ratios (95% CI) of 2.18 (1.00-4.74), 3.44 (1.58-7.47) and 2.41 (1.14-5.11), respectively. Burden of immune dysfunction predicted a progressive increase in risk of infection, from 14% for patients with no dysfunction to 59% for patients with dysfunction of all three markers. The tests failed to risk stratify patients shortly after ICU admission but were effective between days 3 and 9. Conclusions This study confirms our previous findings that three cell surface markers can predict risk of subsequent secondary infection, demonstrates the feasibility of standardized multisite flow cytometry and presents a tool which can be used to target future immunomodulatory therapies. Trial registration The study was registered with clinicaltrials.gov (NCT02186522)., Author(s): Andrew Conway Morris [sup.1] [sup.2], Deepankar Datta [sup.2] [sup.3], Manu Shankar-Hari [sup.4], Jacqueline Stephen [sup.5], Christopher J. Weir [sup.5], Jillian Rennie [sup.2], Jean Antonelli [sup.5], Anthony Bateman [sup.6], Noel [...]

Published
2018
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5. Staff education, regular sedation and analgesia quality feedback, and a sedation monitoring technology for improving sedation and analgesia quality for critically ill, mechanically ventilated patients: a cluster randomised trial

Author

Walsh, Timothy S, Kydonaki, Kalliopi, Antonelli, Jean, Stephen, Jacqueline, Lee, Robert J, Everingham, Kirsty, Hanley, Janet, Phillips, Emma C, Uutela, Kimmo, Peltola, Petra, Cole, Stephen, Quasim, Tara, Ruddy, James, McDougall, Marcia, Davidson, Alan, Rutherford, John, Richards, Jonathan, and Weir, Christopher J

Published
2016
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6. An Inhaled Galectin-3 Inhibitor in COVID-19 Pneumonitis: A Phase Ib/IIa Randomized Controlled Clinical Trial (DEFINE)

Author

Gaughan, Erin E., primary, Quinn, Tom M., additional, Mills, Andrew, additional, Bruce, Annya M., additional, Antonelli, Jean, additional, MacKinnon, Alison C., additional, Aslanis, Vassilios, additional, Li, Feng, additional, O’Connor, Richard, additional, Boz, Cecilia, additional, Mills, Ross, additional, Emanuel, Philip, additional, Burgess, Matthew, additional, Rinaldi, Giulia, additional, Valanciute, Asta, additional, Mills, Bethany, additional, Scholefield, Emma, additional, Hardisty, Gareth, additional, Findlay, Emily Gwyer, additional, Parker, Richard A., additional, Norrie, John, additional, Dear, James W., additional, Akram, Ahsan R., additional, Koch, Oliver, additional, Templeton, Kate, additional, Dockrell, David H., additional, Walsh, Timothy S., additional, Partridge, Stephen, additional, Humphries, Duncan, additional, Wang-Jairaj, Jie, additional, Slack, Robert J., additional, Schambye, Hans, additional, Phung, De, additional, Gravelle, Lise, additional, Lindmark, Bertil, additional, Shankar-Hari, Manu, additional, Hirani, Nikhil, additional, Sethi, Tariq, additional, and Dhaliwal, Kevin, additional

Published
2023
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7. Additional file 1 of Phase 2 randomised placebo-controlled trial of spironolactone and dexamethasone versus dexamethasone in COVID-19 hospitalised patients in Delhi

Author

Wadhwa, Bharti, Malhotra, Vikas, Kerai, Sukhyanti, Husain, Farah, Pandey, Nalini Bala, Saxena, Kirti N., Singh, Vinay, Quinn, Tom M., Li, Feng, Gaughan, Erin, Shankar-Hari, Manu, Mills, Bethany, Antonelli, Jean, Bruce, Annya, Finlayson, Keith, Moore, Anne, Dhaliwal, Kevin, and Edwards, Christopher

Abstract

Additional file 1: Supplementary information. Table S1. Further information on patients withdrawn from the trial due to worsening COVID19/ escalation to WHO Scale >4. Table S2. Summary of adverse events recorded for both groups. Figure S1. Kaplan Meier plot to show risk of patient escalating to WHO OS >4. Figure S2. Additional clinical biomarkers.

Published
2023
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8. Phase 2 randomised placebo-controlled trial of spironolactone and dexamethasone versus dexamethasone in COVID-19 hospitalised patients in Delhi

Author

Wadhwa, Bharti, primary, Malhotra, Vikas, additional, Kerai, Sukhyanti, additional, Husain, Farah, additional, Pandey, Nalini Bala, additional, Saxena, Kirti N, additional, Singh, Vinay, additional, Quinn, Tom M, additional, Li, Feng, additional, Gaughan, Erin, additional, Shankar-Hari, Manu, additional, Mills, Bethany, additional, Antonelli, Jean, additional, Bruce, Annya, additional, Finlayson, Keith, additional, Moore, Anne, additional, Dhaliwal, Kevin, additional, and Edwards, Christopher, additional

Published
2022
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9. Randomised controlled trial of intravenous nafamostat mesylate in COVID pneumonitis: Phase 1b/2a experimental study to investigate safety, Pharmacokinetics and Pharmacodynamics

Author

Quinn, Tom M., primary, Gaughan, Erin E., additional, Bruce, Annya, additional, Antonelli, Jean, additional, O'Connor, Richard, additional, Li, Feng, additional, McNamara, Sarah, additional, Koch, Oliver, additional, MacKintosh, Claire, additional, Dockrell, David, additional, Walsh, Timothy, additional, Blyth, Kevin G., additional, Church, Colin, additional, Schwarze, Jürgen, additional, Boz, Cecilia, additional, Valanciute, Asta, additional, Burgess, Matthew, additional, Emanuel, Philip, additional, Mills, Bethany, additional, Rinaldi, Giulia, additional, Hardisty, Gareth, additional, Mills, Ross, additional, Findlay, Emily Gwyer, additional, Jabbal, Sunny, additional, Duncan, Andrew, additional, Plant, Sinéad, additional, Marshall, Adam D.L., additional, Young, Irene, additional, Russell, Kay, additional, Scholefield, Emma, additional, Nimmo, Alastair F., additional, Nazarov, Islom B., additional, Churchill, Grant C., additional, McCullagh, James S.O., additional, Ebrahimi, Kourosh H., additional, Ferrett, Colin, additional, Templeton, Kate, additional, Rannard, Steve, additional, Owen, Andrew, additional, Moore, Anne, additional, Finlayson, Keith, additional, Shankar-Hari, Manu, additional, Norrie, John, additional, Parker, Richard A., additional, Akram, Ahsan R., additional, Anthony, Daniel C., additional, Dear, James W., additional, Hirani, Nik, additional, and Dhaliwal, Kevin, additional

Published
2022
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10. Evaluation of new or repurposed treatments for COVID-19: protocol for the phase 1b/2a DEFINE trial platform

Author

Gaughan, Erin, Quinn, Tom, Bruce, Annya, Antonelli, Jean, Young, Vikki, Mair, Joanne, Akram, Ahsan, Hirani, Nik, Koch, Oliver, Mackintosh, Claire, Norrie, John, Dear, James W, and Dhaliwal, Kevin

Subjects
infectious disease, COVID-19, Respiratory, pharmacology
Abstract

Introduction; COVID-19 (Coronavirus Disease 2019) is a new viral-induced pneumonia caused by infection with a novel coronavirus, SARS CoV2 (Severe Acute Respiratory Syndrome Coronavirus 2). At present there are few proven effective treatments. This early phase experimental medicine protocol describes an overarching and adaptive trial designed to provide safety data in patients with COVID-19, pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biological surrogates of efficacy, which may support further development and deployment of candidate therapies in larger scale trials of COVID-19 positive patients.Methods and analysis; DEFINE is an ongoing exploratory multicentre platform, open label, randomised study. COVID-19 positive patients will be recruited from the following cohorts; a) community cases b) hospitalised patients with evidence of COVID-19 pneumonitis and c) hospitalised patients requiring assisted ventilation. The cohort recruited from will be dependent on the experimental therapy, its route of administration and mechanism of action. Randomisation will be computer generated in a 1:1:n ratio. Twenty patients will be recruited per arm for the initial two arms. This is permitted to change as per the experimental therapy. The primary statistical analyses are concerned with the safety of candidate agents as add-on therapy to standard of care in patients with COVID-19. Secondary analysis will assess the following variables during treatment period 1) the response of key exploratory biomarkers 2) change in WHO ordinal scale and NEWS2 score 3) oxygen requirements 4) viral load 5) duration of hospital stay 6) PK/PD and 7) changes in key coagulation pathways.

Published
2021

11. C5a-mediated neutrophil dysfunction is RhoA-dependent and predicts infection in critically ill patients

Author

Morris, Andrew Conway, Brittan, Mairi, Wilkinson, Thomas S., McAuley, Danny F., Antonelli, Jean, McCulloch, Corrienne, Barr, Laura C., McDonald, Neil A., Dhaliwal, Kev, Jones, Richard O., Mackellar, Annie, Haslett, Christopher, Hay, Alasdair W., Swann, David G., Anderson, Niall, Laurenson, Ian F., Davidson, Donald J., Rossi, Adriano G., Walsh, Timothy S., and Simpson, A. John

Published
2011
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12. Evaluation of new or repurposed treatments for COVID-19: protocol for the phase Ib/IIa DEFINE trial platform

Author

Gaughan, Erin, primary, Quinn, Tom, additional, Bruce, Annya, additional, Antonelli, Jean, additional, Young, Vikki, additional, Mair, Joanne, additional, Akram, Ahsan, additional, Hirani, Nik, additional, Koch, Oliver, additional, Mackintosh, Claire, additional, Norrie, John, additional, Dear, James W, additional, and Dhaliwal, Kevin, additional

Published
2021
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13. Randomised Controlled Trial of Intravenous Nafamostat Mesylate in COVID pneumonitis: Phase 1b/2a Experimental Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics

Author

Quinn, Tom M., primary, Gaughan, Erin E., additional, Bruce, Annya, additional, Antonelli, Jean, additional, O’Connor, Richard, additional, Li, Feng, additional, McNamara, Sarah, additional, Koch, Oliver, additional, MacIntosh, Claire, additional, Dockrell, David, additional, Walsh, Timothy, additional, Blyth, Kevin G., additional, Church, Colin, additional, Schwarze, Jürgen, additional, Boz, Cecilia, additional, Valanciute, Asta, additional, Burgess, Matthew, additional, Emanuel, Philip, additional, Mills, Bethany, additional, Rinaldi, Giulia, additional, Hardisty, Gareth, additional, Mills, Ross, additional, Findlay, Emily, additional, Jabbal, Sunny, additional, Duncan, Andrew, additional, Plant, Sinéad, additional, Marshall, Adam D. L., additional, Young, Irene, additional, Russell, Kay, additional, Scholefield, Emma, additional, Nimmo, Alastair F., additional, Nazarov, Islom B., additional, Churchill, Grant C., additional, McCullagh, James S.O., additional, Ebrahimi, Kourosh H., additional, Ferrett, Colin, additional, Templeton, Kate, additional, Rannard, Steve, additional, Owen, Andrew, additional, Moore, Anne, additional, Finlayson, Keith, additional, Shankar-Hari, Manu, additional, Norrie, John, additional, Parker, Richard A., additional, Akram, Ahsan R., additional, Anthony, Daniel C., additional, Dear, James W., additional, Hirani, Nik, additional, and Dhaliwal, Kevin, additional

Published
2021
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15. Randomised Controlled Trial of Intravenous Nafamostat Mesylate in COVID Pneumonitis: Phase 1b/2a Experimental Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics

Author

Quinn, Tom Michael, primary, Gaughan, Erin, additional, Bruce, Annya, additional, Antonelli, Jean, additional, O'Connor, Richard, additional, Li, Feng, additional, McNamara, Sarah, additional, Koch, Oliver, additional, MacKintosh, Claire, additional, Dockrell, David H., additional, Walsh, Timothy, additional, Blyth, Kevin, additional, Church, Colin, additional, Schwarze, Jürgen, additional, Boz, Cecilia, additional, Valanciute, Asta, additional, Burgess, Matthew, additional, Emanuel, Philip, additional, Mills, Bethany, additional, Rinaldi, Giulia, additional, Hardisty, Gareth, additional, Mills, Ross, additional, Findlay, Emily, additional, Jabball, Sunny, additional, Duncan, Andrew, additional, Plant, Sinéad, additional, Marshall, Adam D. L., additional, Young, Irene, additional, Russell, Kay, additional, Scholefield, Emma, additional, Nimmo, Alastair F., additional, Nazarov, Islom B., additional, Churchill, Grant C., additional, McCullagh, James S. O., additional, Ebrahimi, Kourosh H., additional, Ferrett, Colin, additional, Templeton, Kate, additional, Rannard, Steve, additional, Owen, Andrew, additional, Moore, Anne, additional, Finlayson, Keith, additional, Shankar-Hari, Manu, additional, Norrie, John, additional, Parker, Richard, additional, Akram, Ahsan R., additional, Anthony, Daniel, additional, Dear, James, additional, Hirani, Nik, additional, and Dhaliwal, Kev, additional

Published
2021
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17. Early PREdiction of Severe Sepsis (ExPRES-Sepsis) study: protocol for an observational derivation study to discover potential leucocyte cell surface biomarkers

Author

Datta, Deepankar, Conway Morris, Andrew, Antonelli, Jean, Warner, Noel, Brown, Kenneth Alun, Wright, John, Simpson, A John, Rennie, Jillian, Hulme, Gillian, Lewis, Sion Marc, Mare, Tracey Anne, Cookson, Sharon, Weir, Christopher John, Dimmick, Ian, Keenan, Jim, Rossi, Adriano Giorgio, Shankar-Hari, Manu, Walsh, Timothy S, ExPRES Sepsis Investigators, Datta, Deepankar [0000-0001-9971-9434], Conway Morris, Andrew [0000-0002-3211-3216], and Apollo - University of Cambridge Repository

Subjects
Adult, Aged, 80 and over, Male, Adolescent, ACCIDENT & EMERGENCY MEDICINE, Critical Illness, Biomarker, Immunologic Tests, Middle Aged, Hospitalization, Young Adult, Scotland, Research Design, Sepsis, Leukocytes, Humans, Female, Prospective Studies, Triage, Emergency Service, Hospital, Biomarkers, Aged
Abstract

INTRODUCTION: Sepsis is an acute illness resulting from infection and the host immune response. Early identification of individuals at risk of developing life-threatening severe sepsis could enable early triage and treatment, and improve outcomes. Currently available biomarkers have poor predictive value for predicting subsequent clinical course in patients with suspected infection. Circulating leucocytes provide readily accessible tissues that reflect many aspects of the complex immune responses described in sepsis. We hypothesise that measuring cellular markers of immune responses by flow cytometry will enable early identification of infected patients at risk of adverse outcomes. We aim to characterise leucocyte surface markers (biomarkers) and their abnormalities in a population of patients presenting to the hospital emergency department with suspected sepsis, and explore their ability to predict subsequent clinical course. METHODS AND ANALYSIS: We will conduct a prospective, multicentre, clinical, exploratory, cohort observational study. To answer our study question, 3 patient populations will be studied. First, patients with suspected sepsis from the emergency department (n=300). To assess performance characteristics of potential tests, critically ill patients with established sepsis, and age and gender matched patients without suspicion of infection requiring hospital admission (both n=100) will be recruited as comparator populations. In all 3 groups, we plan to assess circulating biomarker profiles using flow cytometry. We will select candidate biomarkers by cross-cohort comparison, and then explore their predictive value for clinical outcomes within the cohort with suspected sepsis. ETHICS AND DISSEMINATION: The study will be carried out based on the principles in the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice. Ethics approval has been granted from the Scotland A Research Ethics Committee (REC) and Oxford C REC. On conclusion of this study, the results will be disseminated via peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02188992; Pre-results.

Published
2018
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19. Acute respiratory distress syndrome subphenotypes and differential response to simvastatin: secondary analysis of a randomised controlled trial

Author

Calfee, Carolyn S, primary, Delucchi, Kevin L, additional, Sinha, Pratik, additional, Matthay, Michael A, additional, Hackett, Jonathan, additional, Shankar-Hari, Manu, additional, McDowell, Cliona, additional, Laffey, John G, additional, O'Kane, Cecilia M, additional, McAuley, Daniel F, additional, Johnston, Andrew J, additional, Paikray, Archana, additional, Yates, Cat, additional, Polgarova, Petra, additional, Price, Esther, additional, McInerney, Amy, additional, Zamoscik, Katarzyna, additional, Dempsey, Ged, additional, Seasman, Colette, additional, Gilfeather, Lynn, additional, Hemmings, Noel, additional, O'Kane, Sinead, additional, Johnston, Paul, additional, Pokorny, Lukas, additional, Nutt, Chris, additional, O'Neill, Orla, additional, Prashast, Prashast, additional, Smalley, Chris, additional, Jacob, Reni, additional, O'Rourke, James, additional, Sultan, Syed Farjad, additional, Schilling, Carole, additional, Perkins, Gavin D, additional, Melody, Teresa, additional, Couper, Keith, additional, Daniels, Ron, additional, Gao, Fang, additional, Hull, Julian, additional, Gould, Timothy, additional, Thomas, Matthew, additional, Sweet, Katie, additional, Breen, Dorothy, additional, Neau, Emer, additional, Peel, Willis J, additional, Jardine, Catherine, additional, Jefferson, Paul, additional, Wright, Stephen E, additional, Harris, Kayla, additional, Hierons, Sarah, additional, Laffey, John, additional, McInerney, Veronica, additional, Camporota, Luigi, additional, Lei, Katie, additional, Kaul, Sundeep, additional, Chibvuri, Molly, additional, Gratrix, Andrew, additional, Bennett, Rachael, additional, Martinson, Victoria, additional, Sleight, Lisa, additional, Smith, Neil, additional, Hopkins, Philip A, additional, Hadfield, Daniel, additional, Casboult, Sarah, additional, Wade-Smith, Fiona, additional, Dawson, Julie, additional, Mellis, Clare, additional, Harris, Clair, additional, Parsons, Georgina, additional, Helyar, Sinead, additional, Bodenham, Andrew R, additional, Elliot, Stuart, additional, Beardow, Zoe, additional, Birch, Sian, additional, Marsh, Brian, additional, Martin, Teresa, additional, Dhrampal, Akesh, additional, Rosbergen, Melissa, additional, Webb, Stephen, additional, Bottrill, Fiona, additional, Reschreiter, Henrik, additional, Barcraft-Barnes, Helena, additional, Camsooksai, Julie, additional, Johnston, Andrew, additional, Clarkson, Aisling, additional, Bentley, Conor, additional, Cooper, Lauren, additional, Qui, Yongyan, additional, Mitchell, Natalie, additional, Carrera, Ronald, additional, Whitehouse, Arlo, additional, Danbury, Christopher M, additional, Jacques, Nicola, additional, Brown, Abby, additional, Rogerson, David, additional, Morris, Craig, additional, Walsh, Timothy, additional, Gillies, Mike, additional, Price, Grant, additional, Kefala, Kallirroi, additional, Young, Neil, additional, Hope, David, additional, McCulloch, Corrienne, additional, Antonelli, Jean, additional, Ramsay, Pam, additional, Everingham, Kirsty, additional, Boardman, Louise, additional, Dawson, Heidi, additional, Pollock, Fiona, additional, Thompson, Joanne, additional, Welters, Ingeborg D, additional, Poole, Lee, additional, Hampshire, Peter, additional, Hall, Alison, additional, Williams, Karen, additional, Walker, Anna, additional, Youds, Laura, additional, Hendry, Samantha, additional, Waugh, Victoria, additional, Patrick-Heselton, Julie, additional, Shaw, David, additional, Chaudry, Irfan, additional, Baldwin, Jacqueline, additional, Drage, Stephen, additional, Ortiz-Ruiz de Gordoa, Laura, additional, McAuley, Daniel, additional, Bannon, Leona, additional, Quinn, Vanessa, additional, McNamee, Lia, additional, White, Griania, additional, Cecconi, Maurizio, additional, Mellinghoff, Johannes, additional, Ryan, Donal, additional, Nichol, Alistair, additional, Agarwal, Banwari, additional, Meale, Paula, additional, James, Sarah, additional, Dhadwal, Kulwant, additional, Martin, Daniel, additional, Walecka, Agnieszka, additional, Ward, Stephen, additional, Trinder, John, additional, Hagan, Samantha, additional, Montgomery, Janice, additional, Leonard, Catherine, additional, Lemon, Elizabeth, additional, Trinick, Tom, additional, Buddhavarapu, Murthy, additional, Ward, Geraldine, additional, Bassford, Christopher, additional, Davidson, Alan, additional, McGuigan, Kate, additional, Benchiheub, Anissa, additional, Hickey, Naomi, additional, Binning, Alexander, additional, Henderson, Steven, additional, Wood, J A, additional, Burtenshaw, Andrew J, additional, Kelly, Dawn, additional, Martin, Terry, additional, Thrush, Jessica, additional, Wollaston, Julie, additional, Graystone, Stephen, additional, Nicol, Gavin, additional, and Sellors, Gareth, additional

Published
2018
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20. Rationale, design and methodology of a trial evaluating three strategies designed to improve sedation quality in intensive care units (DESIST study)

Author

Walsh, Timothy S, Kydonaki, Claire (Kalliopi), Antonelli, Jean, Stephen, Jacqueline, Lee, Robert J, Everingham, Kirsty, Hanley, Janet, Uutelo, Kimmo, Peltola, Petra, Weir, Christopher, Kydonaki, Kalliopi, and Weir, Christopher J

Subjects
RT Nursing, sedation, DESIST, 610.73 Nursing, intensive care
Abstract

Objectives To describe the rationale, design and methodology for a trial of three novel interventions developed to improve sedation-analgesia quality in adult intensive care units (ICUs).Participants and Setting 8 clusters, each a Scottish ICU. All mechanically ventilated sedated patients were potentially eligible for inclusion in data analysis.Design Cluster randomised design in 8 ICUs, with ICUs randomised after 45 weeks baseline data collection to implement one of four intervention combinations: a web-based educational programme (2 ICUs); education plus regular sedation quality feedback using process control charts (2 ICUs); education plus a novel sedation monitoring technology (2 ICUs); or all three interventions. ICUs measured sedation-analgesia quality, relevant drug use and clinical outcomes, during a 45-week preintervention and 45-week postintervention period separated by an 8-week implementation period. The intended sample size was >100 patients per site per study period.Main Outcome measures The primary outcome was the proportion of 12 h care periods with optimum sedation-analgesia, defined as the absence of agitation, unnecessary deep sedation, poor relaxation and poor ventilator synchronisation. Secondary outcomes were proportions of care periods with each of these four components of optimum sedation and rates of sedation-related adverse events. Sedative and analgesic drug use, and ICU and hospital outcomes were also measured.Analytic approach Multilevel generalised linear regression mixed models will explore the effects of each intervention taking clustering into account, and adjusting for age, gender and APACHE II score. Sedation-analgesia quality outcomes will be explored at ICU level and individual patient level. A process evaluation using mixed methods including quantitative description of intervention implementation, focus groups and direct observation will provide explanatory information regarding any effects observed.Conclusions The DESIST study uses a novel design to provide system-level evaluation of three contrasting complex interventions on sedation-analgesia quality. Recruitment is complete and analysis ongoing.Trial registration number NCT01634451.

Published
2016

21. Early PREdiction of Severe Sepsis (ExPRES-Sepsis) study: protocol for an observational derivation study to discover potential leucocyte cell surface biomarkers

Author

Datta, Deepankar, primary, Conway Morris, Andrew, additional, Antonelli, Jean, additional, Warner, Noel, additional, Brown, Kenneth Alun, additional, Wright, John, additional, Simpson, A John, additional, Rennie, Jillian, additional, Hulme, Gillian, additional, Lewis, Sion Marc, additional, Mare, Tracey Anne, additional, Cookson, Sharon, additional, Weir, Christopher John, additional, Dimmick, Ian, additional, Keenan, Jim, additional, Rossi, Adriano Giorgio, additional, Shankar-Hari, Manu, additional, and Walsh, Timothy S, additional

Published
2016
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22. Predictive value of cell-surface markers in infections in critically ill patients: protocol for an observational study (ImmuNe FailurE in Critical Therapy (INFECT) Study)

Author

Conway Morris, Andrew, primary, Datta, Deepankar, additional, Shankar-Hari, Manu, additional, Weir, Christopher J, additional, Rennie, Jillian, additional, Antonelli, Jean, additional, Rossi, Adriano G, additional, Warner, Noel, additional, Keenan, Jim, additional, Wang, Alice, additional, Brown, K Alun, additional, Lewis, Sion, additional, Mare, Tracey, additional, Simpson, A John, additional, Hulme, Gillian, additional, Dimmick, Ian, additional, and Walsh, Timothy S, additional

Published
2016
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23. Development of Process Control Methodology for Tracking the Quality and Safety of Pain, Agitation, and Sedation Management in Critical Care Units

Author

Walsh, Timothy S., primary, Kydonaki, Kalliopi, additional, Lee, Robert J., additional, Everingham, Kirsty, additional, Antonelli, Jean, additional, Harkness, Ronald T., additional, Cole, Stephen, additional, Quasim, Tara, additional, Ruddy, James, additional, McDougall, Marcia, additional, Davidson, Alan, additional, Rutherford, John, additional, Richards, Jonathan, additional, and Weir, Christopher J., additional

Published
2016
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24. Stratégie, méthodes et enjeux de la gestion du mouflon (Ovis gmelini musimon var. corsicana) en Corse à travers un projet LIFE-Nature

Author

Mattei, César, Benedetti, Pierre, Bideau, Eric, Richard, Franck, Mariani, Jean-Paul, Aledo, Emmanuel, Antonelli, Jean, Orsetti, François, Muraccioli, Véronique, Castelli, Marie-Luce, Recorbet, Bernard, Feracci, Gérard, Parc Naturel Régional de Corse, Office National de la Chasse et de la Faune Sauvage (ONCFS), Unité de recherche Comportement et Ecologie de la Faune Sauvage (CEFS), Institut National de la Recherche Agronomique (INRA), Office National des Forêts (ONF), Office Environnement Corse, Direction Régionale de l'Environnement, and ProdInra, Migration

Subjects
RELEASE, MOUFLON, LIFE PROGRAM, SENSITISATION EFFORT, [SDV]Life Sciences [q-bio], OVIS GMELINI MUSIMON VAR.CORSICANA, COMMON MANAGEMENT, [SDV] Life Sciences [q-bio], CAPTURE, CORSICAN MOUFLON, CONSERVATION POLICY, NATURA 2000 NETWORK, PROJET LIFE-NATURE, ECOLOGIE, BREEDING
Abstract

National audience; Cet article se propose d'éclairer les différentes orientations de travail choisies par les partenaires du projet LIFE-Nature « Conservation et extension des populations de mouflons corses en Corse », mis en oeuvre dans le cadre du réseau Natura 2000. Il ne propose nullement de résultats scientifiques, même préliminaires, des études actuellement menées dans le cadre de ce programme. Il ambitionne simplement d'expliquer les enjeux d'une gestion concertée du mouflon en Corse, initiée à travers ce projet LIFE. Il décrit l'essentiel des actions menées et les méthodes employées. D'autres publications suivront, co-signées par les partenaires du projet, et destinées à présenter les données scientifiques générées par les études qui auront abouti dans les thématiques particulières relatives aux aspects de cette politique de gestion: méthodologies de captures, étude de la dynamique de population, utilisation de l'habitat par les animaux, étude du parasitisme...

Published
2005

25. Predictive value of cell-surface markers in infections in critically ill patients: protocol for an observational study (ImmuNe FailurE in Critical Therapy (INFECT) Study).

Author

Morris, Andrew Conway, Datta, Deepankar, Shankar-Hari, Manu, Weir, Christopher J., Rennie, Jillian, Antonelli, Jean, Rossi, Adriano G., Warner, Noel, Keenan, Jim, Wang, Alice, Brown, K. Alun, Lewis, Sion, Mare, Tracey, Simpson, A. John, Hulme, Gillian, Dimmick, Ian, and Walsh, Timothy S.

Abstract

Introduction: Critically ill patients are at high risk of nosocomial infections, with between 20% and 40% of patients admitted to the intensive care unit (ICU) acquiring infections. These infections result in increased antibiotic use, and are associated with morbidity and mortality. Although critical illness is classically associated with hyperinflammation, the high rates of nosocomial infection argue for an importance of effect of impaired immunity. Our group recently demonstrated that a combination of 3 measures of immune cell function (namely neutrophil CD88, monocyte HLA-DR and % regulatory T cells) identified a patient population with a 2.4-5-fold greater risk for susceptibility to nosocomial infections. Methods and analysis: This is a prospective, observational study to determine whether previously identified markers of susceptibility to nosocomial infection can be validated in a multicentre population, as well as testing several novel markers which may improve the risk of nosocomial infection prediction. Blood samples from critically ill patients (those admitted to the ICU for at least 48 hours and requiring mechanical ventilation alone or support of 2 or more organ systems) are taken and undergo whole blood staining for a range of immune cell surface markers. These samples undergo analysis on a standardised flow cytometry platform. Patients are followed up to determine whether they develop nosocomial infection. Infections need to meet strict prespecified criteria based on international guidelines; where these criteria are not met, an adjudication panel of experienced intensivists is asked to rule on the presence of infection. Secondary outcomes will be death from severe infection (sepsis) and change in organ failure. Ethics and dissemination: Ethical approval including the involvement of adults lacking capacity has been obtained from respective English and Scottish Ethics Committees. Results will be disseminated through presentations at scientific meetings and publications in peer-reviewed journals. [ABSTRACT FROM AUTHOR]

Published
2016
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26. Cell-surface signatures of immune dysfunction risk-stratify critically ill patients: INFECT study

Author

Conway Morris, Andrew, Datta, Deepankar, Shankar-Hari, Manu, Stephen, Jacqueline, Weir, Christopher J, Rennie, Jillian, Antonelli, Jean, Bateman, Anthony, Warner, Noel, Judge, Kevin, Keenan, Jim, Wang, Alice, Burpee, Tony, Brown, K Alun, Lewis, Sion M, Mare, Tracey, Roy, Alistair I, Hulme, Gillian, Dimmick, Ian, Rossi, Adriano G, Simpson, A John, and Walsh, Timothy S

Subjects
Male, Neutrophils, Critical Illness, HLA-DR Antigens, Middle Aged, Immunoparesis, T-lymphocytes, regulatory, Risk Assessment, Monocytes, 3. Good health, Immunophenotyping, Intensive Care Units, Cross infection, Immune System Diseases, Predictive Value of Tests, Humans, Female, Prospective Studies, Receptor, Anaphylatoxin C5a, Aged
Abstract

PURPOSE: Cellular immune dysfunctions, which are common in intensive care patients, predict a number of significant complications. In order to effectively target treatments, clinically applicable measures need to be developed to detect dysfunction. The objective was to confirm the ability of cellular markers associated with immune dysfunction to stratify risk of secondary infection in critically ill patients. METHODS: Multi-centre, prospective observational cohort study of critically ill patients in four UK intensive care units. Serial blood samples were taken, and three cell surface markers associated with immune cell dysfunction [neutrophil CD88, monocyte human leucocyte antigen-DR (HLA-DR) and percentage of regulatory T cells (Tregs)] were assayed on-site using standardized flow cytometric measures. Patients were followed up for the development of secondary infections. RESULTS: A total of 148 patients were recruited, with data available from 138. Reduced neutrophil CD88, reduced monocyte HLA-DR and elevated proportions of Tregs were all associated with subsequent development of infection with odds ratios (95% CI) of 2.18 (1.00-4.74), 3.44 (1.58-7.47) and 2.41 (1.14-5.11), respectively. Burden of immune dysfunction predicted a progressive increase in risk of infection, from 14% for patients with no dysfunction to 59% for patients with dysfunction of all three markers. The tests failed to risk stratify patients shortly after ICU admission but were effective between days 3 and 9. CONCLUSIONS: This study confirms our previous findings that three cell surface markers can predict risk of subsequent secondary infection, demonstrates the feasibility of standardized multisite flow cytometry and presents a tool which can be used to target future immunomodulatory therapies. TRIAL REGISTRATION: The study was registered with clinicaltrials.gov (NCT02186522).

27. Rationale, design and methodology of a trial evaluating three strategies designed to improve sedation quality in intensive care units (DESIST study).

Author

Walsh TS, Kydonaki K, Antonelli J, Stephen J, Lee RJ, Everingham K, Hanley J, Uutelo K, Peltola P, and Weir CJ

Subjects
Cluster Analysis, Female, Humans, Male, Process Assessment, Health Care methods, Quality Improvement, Scotland epidemiology, Analgesia methods, Critical Care standards, Hypnotics and Sedatives administration & dosage, Intensive Care Units standards, Monitoring, Physiologic standards, Respiration, Artificial methods
Abstract

Objectives: To describe the rationale, design and methodology for a trial of three novel interventions developed to improve sedation-analgesia quality in adult intensive care units (ICUs)., Participants and Setting: 8 clusters, each a Scottish ICU. All mechanically ventilated sedated patients were potentially eligible for inclusion in data analysis., Design: Cluster randomised design in 8 ICUs, with ICUs randomised after 45 weeks baseline data collection to implement one of four intervention combinations: a web-based educational programme (2 ICUs); education plus regular sedation quality feedback using process control charts (2 ICUs); education plus a novel sedation monitoring technology (2 ICUs); or all three interventions. ICUs measured sedation-analgesia quality, relevant drug use and clinical outcomes, during a 45-week preintervention and 45-week postintervention period separated by an 8-week implementation period. The intended sample size was >100 patients per site per study period., Main Outcome Measures: The primary outcome was the proportion of 12 h care periods with optimum sedation-analgesia, defined as the absence of agitation, unnecessary deep sedation, poor relaxation and poor ventilator synchronisation. Secondary outcomes were proportions of care periods with each of these four components of optimum sedation and rates of sedation-related adverse events. Sedative and analgesic drug use, and ICU and hospital outcomes were also measured., Analytic Approach: Multilevel generalised linear regression mixed models will explore the effects of each intervention taking clustering into account, and adjusting for age, gender and APACHE II score. Sedation-analgesia quality outcomes will be explored at ICU level and individual patient level. A process evaluation using mixed methods including quantitative description of intervention implementation, focus groups and direct observation will provide explanatory information regarding any effects observed., Conclusions: The DESIST study uses a novel design to provide system-level evaluation of three contrasting complex interventions on sedation-analgesia quality. Recruitment is complete and analysis ongoing., Trial Registration Number: NCT01634451., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Published
2016
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