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
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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