Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan
Autor: | Peter Buhl Hjortrup, Christoffer Sølling, Marlies Ostermann, Andreas Bender Jonsson, Marianne Vang, Iwan C. C. van der Horst, Lars Nebrich, Ville Pettilä, Marek Nalos, Lene Russell, Paul R Mouncey, Christian Ahlstedt, Theis Lange, Jørn Wetterslev, Ricard Ferrer, Anders Perner, Morten H. Bestle, Anne Craveiro Brøchner, Maj-Brit Nørregaard Kjaer, Morten Hylander Møller, Maurizio Cecconi, Jon Henrik Laake, Søren Hoffmann, Carl Johan Steensen Hjortsø, Stephan M. Jakob, Maria Cronhjort, Bodil Steen Rasmussen, Tine Sylvest Meyhoff, Michael Lindhardt Rasmussen, Kathy Rowan, Manu L N G Malbrain |
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Přispěvatelé: | Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), Cardiovascular Centre (CVC), HUS Perioperative, Intensive Care and Pain Medicine, Department of Diagnostics and Therapeutics, University Management, University of Helsinki, Anestesiologian yksikkö, Supporting clinical sciences, Intensive Care |
Jazyk: | angličtina |
Rok vydání: | 2019 |
Předmět: |
Male
Research design law.invention Cognition 0302 clinical medicine Clinical Protocols Randomized controlled trial Quality of life law 030212 general & internal medicine VOLUMES Aged 80 and over education.field_of_study RESUSCITATION General Medicine Middle Aged Shock Septic 3. Good health Clinical equipoise Treatment Outcome Research Design Data Interpretation Statistical Shock (circulatory) Female medicine.symptom Adult medicine.medical_specialty Critical Care Population INTENSIVE-CARE 03 medical and health sciences Double-Blind Method MISSING DATA Intensive care Pragmatic Clinical Trials as Topic medicine MANAGEMENT Humans SEPSIS-PROTOCOL education Aged Septic shock business.industry MORTALITY 030208 emergency & critical care medicine ADULTS 3126 Surgery anesthesiology intensive care radiology medicine.disease Logistic Models Anesthesiology and Pain Medicine Emergency medicine Quality of Life Fluid Therapy business |
Zdroj: | Acta Anaesthesiologica Scandinavica, 63(9), 1262-1271. Wiley Meyhoff, T S, Hjortrup, P B, Møller, M H, Wetterslev, J, Lange, T, Kjaer, M-B N, Jonsson, A B, Hjortsø, C J S, Cronhjort, M, Laake, J H, Jakob, S M, Nalos, M, Pettilä, V, van der Horst, I, Ostermann, M, Mouncey, P, Rowan, K, Cecconi, M, Ferrer, R, Malbrain, M L N G, Ahlstedt, C, Hoffmann, S, Bestle, M H, Nebrich, L, Russell, L, Vang, M, Rasmussen, M L, Sølling, C, Rasmussen, B S, Brøchner, A C & Perner, A 2019, ' Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial—Protocol and statistical analysis plan ', Acta Anaesthesiologica Scandinavica, vol. 63, no. 9, pp. 1262-1271 . https://doi.org/10.1111/aas.13434 Meyhoff, T S, Hjortrup, P B, Møller, M H, Wetterslev, J, Lange, T, Kjaer, M-B N, Jonsson, A B, Hjortsø, C J S, Cronhjort, M, Laake, J H, Jakob, S M, Nalos, M, Pettilä, V, van der Horst, I, Ostermann, M, Mouncey, P, Rowan, K, Cecconi, M, Ferrer, R, Malbrain, M L N G, Ahlstedt, C, Hoffmann, S, Bestle, M H, Nebrich, L, Russell, L, Vang, M, Rasmussen, M L, Sølling, C, Rasmussen, B S, Brøchner, A C & Perner, A 2019, ' Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan ', Acta Anaesthesiologica Scandinavica, vol. 63, no. 9, pp. 1262-1271 . https://doi.org/10.1111/aas.13434 Meyhoff, T S, Hjortrup, P B, Møller, M H, Wetterslev, J, Lange, T, Kjaer, M-B N, Jonsson, A B, Hjortsø, C J S, Cronhjort, M, Laake, J H, Jakob, S M, Nalos, M, Pettilä, V, van der Horst, I, Ostermann, M, Mouncey, P, Rowan, K, Cecconi, M, Ferrer, R, Malbrain, M L N G, Ahlstedt, C, Hoffmann, S, Bestle, M H, Nebrich, L, Russell, L, Vang, M, Rasmussen, M L, Sølling, C, Rasmussen, B S, Brøchner, A C & Perner, A 2019, ' Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial : Protocol and statistical analysis plan ', Acta Anaesthesiologica Scandinavica, vol. 63, no. 9, pp. 1262-1271 . https://doi.org/10.1111/aas.13434 Meyhoff, T S, Hjortrup, P B, Møller, M H, Wetterslev, J, Lange, T, Kjær, M-B N, Jonsson, A B, Hjortsø, C J S, Cronhjort, M, Laake, J H, Jakob, S M, Nalos, M, Pettilä, V, van der Horst, I, Ostermann, M, Mouncey, P, Rowan, K, Cecconi, M, Ferrer, R, Malbrain, M L N G, Ahlstedt, C, Hoffmann, S, Bestle, M H, Nebrich, L, Russell, L, Vang, M, Rasmussen, M L, Sølling, C, Rasmussen, B S, Brøchner, A C & Perner, A 2019, ' Conservative versus Liberal fluid therapy in Septic Shock (CLASSIC) trial-protocol and statistical analysis plan ', Acta Anaesthesiologica Scandinavica, vol. 63, no. 9, pp. 1262-1271 . https://doi.org/10.1111/aas.13434 |
ISSN: | 0001-5172 |
Popis: | INTRODUCTION: Intravenous (IV) fluid is a key intervention in the management of septic shock. The benefits and harms of lower versus higher fluid volumes are unknown and clinical equipoise exists. We describe the protocol and detailed statistical analysis plan for the Conservative versus Liberal Approach to fluid therapy of Septic Shock in the Intensive Care (CLASSIC) trial. The aim of the CLASSIC trial is to assess benefits and harms of IV fluid restriction versus standard care in adult intensive care unit (ICU) patients with septic shock.METHODS: CLASSIC trial is an investigator-initiated, international, randomised, stratified, and analyst-blinded trial. We will allocate 1554 adult patients with septic shock, who are planned to be or are admitted to an ICU, to IV fluid restriction versus standard care. The primary outcome is mortality at day 90. Secondary outcomes are serious adverse events, serious adverse reactions, days alive at day 90 without life support, days alive and out of hospital at day 90, and mortality, health-related quality of life, and cognitive function at 1 year. We will conduct the statistical analyses according to a pre-defined statistical analysis plan, including three interim analyses. For the primary analysis we will use logistic regression adjusted for the stratification variables comparing the two interventions in the intention-to-treat population.DISCUSSION: The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding IV fluid therapy in adults with septic shock. This article is protected by copyright. All rights reserved. |
Databáze: | OpenAIRE |
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