Publication

Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan

Meyhoff, T. S., Hjortrup, P. B., Moller, M. H., Wetterslev, J., Lange, T., Kjaer, M-B. N., Jonsson, A. B., Hjortso, C. J. S., Cronhjort, M., Laake, J. H., Jakob, S. M., Nalos, M., Pettila, 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., Solling, C., Rasmussen, B. S., Brochner, A. C. & Perner, A., Oct-2019, In : Acta Anaesthesiologica Scandinavica. 63, 9, p. 1262-1271 10 p.

Research output: Contribution to journalArticleAcademicpeer-review

APA

Meyhoff, T. S., Hjortrup, P. B., Moller, M. H., Wetterslev, J., Lange, T., Kjaer, M-B. N., ... Perner, A. (2019). Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan. Acta Anaesthesiologica Scandinavica, 63(9), 1262-1271. https://doi.org/10.1111/aas.13434

Author

Meyhoff, Tine Sylvest ; Hjortrup, Peter Buhl ; Moller, Morten Hylander ; Wetterslev, Jorn ; Lange, Theis ; Kjaer, Maj-Brit Norregaard ; Jonsson, Andreas Bender ; Hjortso, Carl Johan Steensen ; Cronhjort, Maria ; Laake, Jon Henrik ; Jakob, Stephan M. ; Nalos, Marek ; Pettila, Ville ; van der Horst, Iwan ; Ostermann, Marlies ; Mouncey, Paul ; Rowan, Kathy ; Cecconi, Maurizio ; Ferrer, Ricard ; Malbrain, Manu L. N. G. ; Ahlstedt, Christian ; Hoffmann, Soren ; Bestle, Morten Heiberg ; Nebrich, Lars ; Russell, Lene ; Vang, Marianne ; Rasmussen, Michael Lindhardt ; Solling, Christoffer ; Rasmussen, Bodil Steen ; Brochner, Anne Craveiro ; Perner, Anders. / Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan. In: Acta Anaesthesiologica Scandinavica. 2019 ; Vol. 63, No. 9. pp. 1262-1271.

Harvard

Meyhoff, TS, Hjortrup, PB, Moller, MH, Wetterslev, J, Lange, T, Kjaer, M-BN, Jonsson, AB, Hjortso, CJS, Cronhjort, M, Laake, JH, Jakob, SM, Nalos, M, Pettila, V, van der Horst, I, Ostermann, M, Mouncey, P, Rowan, K, Cecconi, M, Ferrer, R, Malbrain, MLNG, Ahlstedt, C, Hoffmann, S, Bestle, MH, Nebrich, L, Russell, L, Vang, M, Rasmussen, ML, Solling, C, Rasmussen, BS, Brochner, AC & 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

Standard

Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan. / Meyhoff, Tine Sylvest; Hjortrup, Peter Buhl; Moller, Morten Hylander; Wetterslev, Jorn; Lange, Theis; Kjaer, Maj-Brit Norregaard; Jonsson, Andreas Bender; Hjortso, Carl Johan Steensen; Cronhjort, Maria; Laake, Jon Henrik; Jakob, Stephan M.; Nalos, Marek; Pettila, Ville; van der Horst, Iwan; Ostermann, Marlies; Mouncey, Paul; Rowan, Kathy; Cecconi, Maurizio; Ferrer, Ricard; Malbrain, Manu L. N. G.; Ahlstedt, Christian; Hoffmann, Soren; Bestle, Morten Heiberg; Nebrich, Lars; Russell, Lene; Vang, Marianne; Rasmussen, Michael Lindhardt; Solling, Christoffer; Rasmussen, Bodil Steen; Brochner, Anne Craveiro; Perner, Anders.

In: Acta Anaesthesiologica Scandinavica, Vol. 63, No. 9, 10.2019, p. 1262-1271.

Research output: Contribution to journalArticleAcademicpeer-review

Vancouver

Meyhoff TS, Hjortrup PB, Moller MH, Wetterslev J, Lange T, Kjaer M-BN et al. Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan. Acta Anaesthesiologica Scandinavica. 2019 Oct;63(9):1262-1271. https://doi.org/10.1111/aas.13434


BibTeX

@article{7d48b69526f74526a6e781dbd8239d78,
title = "Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan",
abstract = "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 thus 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 (SAEs), serious adverse reactions (SARs), days alive at day 90 without life support, days alive and out of the hospital at day 90 and mortality, health-related quality of life (HRQoL), 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 (ITT) population. Discussion The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock.",
keywords = "INTENSIVE-CARE, SEPSIS-PROTOCOL, MISSING DATA, RESUSCITATION, MANAGEMENT, MORTALITY, VOLUMES, ADULTS",
author = "Meyhoff, {Tine Sylvest} and Hjortrup, {Peter Buhl} and Moller, {Morten Hylander} and Jorn Wetterslev and Theis Lange and Kjaer, {Maj-Brit Norregaard} and Jonsson, {Andreas Bender} and Hjortso, {Carl Johan Steensen} and Maria Cronhjort and Laake, {Jon Henrik} and Jakob, {Stephan M.} and Marek Nalos and Ville Pettila and {van der Horst}, Iwan and Marlies Ostermann and Paul Mouncey and Kathy Rowan and Maurizio Cecconi and Ricard Ferrer and Malbrain, {Manu L. N. G.} and Christian Ahlstedt and Soren Hoffmann and Bestle, {Morten Heiberg} and Lars Nebrich and Lene Russell and Marianne Vang and Rasmussen, {Michael Lindhardt} and Christoffer Solling and Rasmussen, {Bodil Steen} and Brochner, {Anne Craveiro} and Anders Perner",
year = "2019",
month = "10",
doi = "10.1111/aas.13434",
language = "English",
volume = "63",
pages = "1262--1271",
journal = "Acta Anaesthesiologica Scandinavica",
issn = "0001-5172",
publisher = "WILEY",
number = "9",

}

RIS

TY - JOUR

T1 - Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan

AU - Meyhoff, Tine Sylvest

AU - Hjortrup, Peter Buhl

AU - Moller, Morten Hylander

AU - Wetterslev, Jorn

AU - Lange, Theis

AU - Kjaer, Maj-Brit Norregaard

AU - Jonsson, Andreas Bender

AU - Hjortso, Carl Johan Steensen

AU - Cronhjort, Maria

AU - Laake, Jon Henrik

AU - Jakob, Stephan M.

AU - Nalos, Marek

AU - Pettila, Ville

AU - van der Horst, Iwan

AU - Ostermann, Marlies

AU - Mouncey, Paul

AU - Rowan, Kathy

AU - Cecconi, Maurizio

AU - Ferrer, Ricard

AU - Malbrain, Manu L. N. G.

AU - Ahlstedt, Christian

AU - Hoffmann, Soren

AU - Bestle, Morten Heiberg

AU - Nebrich, Lars

AU - Russell, Lene

AU - Vang, Marianne

AU - Rasmussen, Michael Lindhardt

AU - Solling, Christoffer

AU - Rasmussen, Bodil Steen

AU - Brochner, Anne Craveiro

AU - Perner, Anders

PY - 2019/10

Y1 - 2019/10

N2 - 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 thus 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 (SAEs), serious adverse reactions (SARs), days alive at day 90 without life support, days alive and out of the hospital at day 90 and mortality, health-related quality of life (HRQoL), 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 (ITT) population. Discussion The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock.

AB - 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 thus 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 (SAEs), serious adverse reactions (SARs), days alive at day 90 without life support, days alive and out of the hospital at day 90 and mortality, health-related quality of life (HRQoL), 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 (ITT) population. Discussion The CLASSIC trial results will provide important evidence to guide clinicians' choice regarding the IV fluid therapy in adults with septic shock.

KW - INTENSIVE-CARE

KW - SEPSIS-PROTOCOL

KW - MISSING DATA

KW - RESUSCITATION

KW - MANAGEMENT

KW - MORTALITY

KW - VOLUMES

KW - ADULTS

U2 - 10.1111/aas.13434

DO - 10.1111/aas.13434

M3 - Article

VL - 63

SP - 1262

EP - 1271

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

IS - 9

ER -

ID: 96878942