Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock: A pilot randomized, controlled trial

Lauralyn A. McIntyre; Dean A. Fergusson; Deborah J. Cook; Brian H. Rowe; Sean M. Bagshaw; Dave Easton; Marcel Emond; Simon Finfer; Alison Fox-Robichaud; Claude Gaudert; Robert Green; Paul Hebert; John Marshall; Nigel Rankin; Ian Stiell; Alan Tinmouth; Joe Pagliarello; Alexis F. Turgeon; Andrew Worster; Ryan Zarychanski

doi:10.1016/j.jcrc.2011.10.007

Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock: A pilot randomized, controlled trial

Lauralyn A. McIntyre, Dean A. Fergusson, Deborah J. Cook, Brian H. Rowe, Sean M. Bagshaw, Dave Easton, Marcel Emond, Simon Finfer, Alison Fox-Robichaud, Claude Gaudert, Robert Green, Paul Hebert, John Marshall, Nigel Rankin, Ian Stiell, Alan Tinmouth, Joe Pagliarello, Alexis F. Turgeon, Andrew Worster, Ryan Zarychanski

Research output: Contribution to journal › Article › peer-review

16 Citations (Scopus)

Abstract

Purpose: Randomized, controlled trials of fluid resuscitation in early septic shock face many logistic challenges. We describe the Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock (PRECISE) pilot trial study design and report feasibility of patient recruitment. Materials and Methods: Six Canadian academic centers enrolled adult patients with early suspected septic shock from the emergency department and intensive care unit department. Consent was deferred. Using concealed allocation, participants were randomized to either 5% albumin or 0.9% sodium chloride. Blinded fluid resuscitation started immediately and continued for 7 days in the intensive care unit. Target recruitment was established a priori at 2 patients per site per month. Results: Fifty-one patients were enrolled; 50 patients received study fluid. We recruited a median of 2.5 patients (interquartile range [IQR], 1.5-3.0) per site per month into the trial. Median age and Acute Physiology and Chronic Health Evaluation II scores were 64.5 (IQR, 55.0-78.0) and 25.0 (IQR, 20.0-29.0), respectively. Most patients (n = 37 [74.0%]) were enrolled from the emergency department for a median of 1.6 hours (IQR, 0.8-3.5 hours) from their first hypotensive event and received a median of 2.4 L (IQR, 1.5-3.0 L) of resuscitation fluid before inclusion. Consent was deferred for 44 patients (89.8%). Conclusions: Patient recruitment into the PRECISE pilot trial met our prespecified feasibility targets, and the PRECISE team is planning the larger trial.

Original language	English
Pages (from-to)	317.e1-317.e6
Journal	Journal of Critical Care
Volume	27
Issue number	3
DOIs	https://doi.org/10.1016/j.jcrc.2011.10.007
Publication status	Published - Jun 2012
Externally published	Yes

Bibliographical note

Funding Information:
Dr McIntyre holds a joint New Investigator award from the Canadian Institutes of Health Research (CIHR) and Canadian Blood Services. Dr Fergusson holds a New Investigator award from CIHR. Drs Rowe and Cook are supported by the 21st Century Canada Research Chairs program through the CIHR and the Government of Canada (Ottawa, Ontario, Canada). Dr Stiell holds a Distinguished Professorship and University Health Research Chair from the University of Ottawa. Dr Turgeon holds a Research Career Award from the Fonds de la Recherche en Santé du Québec.

Funding Information:
Conflicts of Interest: Dr McIntyre received joint funding from the Canadian Institute of Health Research and CSL Behring to hold 2 PRECISE planning meetings. Dr Finfer received partial funding for the SAFE trial and travel funding for industry sponsored and academic meetings from CSL Behring.

ASJC Scopus Subject Areas

Critical Care and Intensive Care Medicine

PubMed: MeSH publication types

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

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10.1016/j.jcrc.2011.10.007

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McIntyre, L. A., Fergusson, D. A., Cook, D. J., Rowe, B. H., Bagshaw, S. M., Easton, D., Emond, M., Finfer, S., Fox-Robichaud, A., Gaudert, C., Green, R., Hebert, P., Marshall, J., Rankin, N., Stiell, I., Tinmouth, A., Pagliarello, J., Turgeon, A. F., Worster, A., & Zarychanski, R. (2012). Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock: A pilot randomized, controlled trial. Journal of Critical Care, 27(3), 317.e1-317.e6. https://doi.org/10.1016/j.jcrc.2011.10.007

McIntyre, LA, Fergusson, DA, Cook, DJ, Rowe, BH, Bagshaw, SM, Easton, D, Emond, M, Finfer, S, Fox-Robichaud, A, Gaudert, C, Green, R, Hebert, P, Marshall, J, Rankin, N, Stiell, I, Tinmouth, A, Pagliarello, J, Turgeon, AF, Worster, A & Zarychanski, R 2012, 'Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock: A pilot randomized, controlled trial', Journal of Critical Care, vol. 27, no. 3, pp. 317.e1-317.e6. https://doi.org/10.1016/j.jcrc.2011.10.007

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abstract = "Purpose: Randomized, controlled trials of fluid resuscitation in early septic shock face many logistic challenges. We describe the Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock (PRECISE) pilot trial study design and report feasibility of patient recruitment. Materials and Methods: Six Canadian academic centers enrolled adult patients with early suspected septic shock from the emergency department and intensive care unit department. Consent was deferred. Using concealed allocation, participants were randomized to either 5% albumin or 0.9% sodium chloride. Blinded fluid resuscitation started immediately and continued for 7 days in the intensive care unit. Target recruitment was established a priori at 2 patients per site per month. Results: Fifty-one patients were enrolled; 50 patients received study fluid. We recruited a median of 2.5 patients (interquartile range [IQR], 1.5-3.0) per site per month into the trial. Median age and Acute Physiology and Chronic Health Evaluation II scores were 64.5 (IQR, 55.0-78.0) and 25.0 (IQR, 20.0-29.0), respectively. Most patients (n = 37 [74.0%]) were enrolled from the emergency department for a median of 1.6 hours (IQR, 0.8-3.5 hours) from their first hypotensive event and received a median of 2.4 L (IQR, 1.5-3.0 L) of resuscitation fluid before inclusion. Consent was deferred for 44 patients (89.8%). Conclusions: Patient recruitment into the PRECISE pilot trial met our prespecified feasibility targets, and the PRECISE team is planning the larger trial.",

author = "McIntyre, {Lauralyn A.} and Fergusson, {Dean A.} and Cook, {Deborah J.} and Rowe, {Brian H.} and Bagshaw, {Sean M.} and Dave Easton and Marcel Emond and Simon Finfer and Alison Fox-Robichaud and Claude Gaudert and Robert Green and Paul Hebert and John Marshall and Nigel Rankin and Ian Stiell and Alan Tinmouth and Joe Pagliarello and Turgeon, {Alexis F.} and Andrew Worster and Ryan Zarychanski",

note = "Funding Information: Dr McIntyre holds a joint New Investigator award from the Canadian Institutes of Health Research (CIHR) and Canadian Blood Services. Dr Fergusson holds a New Investigator award from CIHR. Drs Rowe and Cook are supported by the 21st Century Canada Research Chairs program through the CIHR and the Government of Canada (Ottawa, Ontario, Canada). Dr Stiell holds a Distinguished Professorship and University Health Research Chair from the University of Ottawa. Dr Turgeon holds a Research Career Award from the Fonds de la Recherche en Sant{\'e} du Qu{\'e}bec. Funding Information: Conflicts of Interest: Dr McIntyre received joint funding from the Canadian Institute of Health Research and CSL Behring to hold 2 PRECISE planning meetings. Dr Finfer received partial funding for the SAFE trial and travel funding for industry sponsored and academic meetings from CSL Behring. ",

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T1 - Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock

T2 - A pilot randomized, controlled trial

AU - McIntyre, Lauralyn A.

AU - Fergusson, Dean A.

AU - Cook, Deborah J.

AU - Rowe, Brian H.

AU - Bagshaw, Sean M.

AU - Easton, Dave

AU - Emond, Marcel

AU - Finfer, Simon

AU - Fox-Robichaud, Alison

AU - Gaudert, Claude

AU - Green, Robert

AU - Hebert, Paul

AU - Marshall, John

AU - Rankin, Nigel

AU - Stiell, Ian

AU - Tinmouth, Alan

AU - Pagliarello, Joe

AU - Turgeon, Alexis F.

AU - Worster, Andrew

AU - Zarychanski, Ryan

N1 - Funding Information: Dr McIntyre holds a joint New Investigator award from the Canadian Institutes of Health Research (CIHR) and Canadian Blood Services. Dr Fergusson holds a New Investigator award from CIHR. Drs Rowe and Cook are supported by the 21st Century Canada Research Chairs program through the CIHR and the Government of Canada (Ottawa, Ontario, Canada). Dr Stiell holds a Distinguished Professorship and University Health Research Chair from the University of Ottawa. Dr Turgeon holds a Research Career Award from the Fonds de la Recherche en Santé du Québec. Funding Information: Conflicts of Interest: Dr McIntyre received joint funding from the Canadian Institute of Health Research and CSL Behring to hold 2 PRECISE planning meetings. Dr Finfer received partial funding for the SAFE trial and travel funding for industry sponsored and academic meetings from CSL Behring.

PY - 2012/6

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N2 - Purpose: Randomized, controlled trials of fluid resuscitation in early septic shock face many logistic challenges. We describe the Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock (PRECISE) pilot trial study design and report feasibility of patient recruitment. Materials and Methods: Six Canadian academic centers enrolled adult patients with early suspected septic shock from the emergency department and intensive care unit department. Consent was deferred. Using concealed allocation, participants were randomized to either 5% albumin or 0.9% sodium chloride. Blinded fluid resuscitation started immediately and continued for 7 days in the intensive care unit. Target recruitment was established a priori at 2 patients per site per month. Results: Fifty-one patients were enrolled; 50 patients received study fluid. We recruited a median of 2.5 patients (interquartile range [IQR], 1.5-3.0) per site per month into the trial. Median age and Acute Physiology and Chronic Health Evaluation II scores were 64.5 (IQR, 55.0-78.0) and 25.0 (IQR, 20.0-29.0), respectively. Most patients (n = 37 [74.0%]) were enrolled from the emergency department for a median of 1.6 hours (IQR, 0.8-3.5 hours) from their first hypotensive event and received a median of 2.4 L (IQR, 1.5-3.0 L) of resuscitation fluid before inclusion. Consent was deferred for 44 patients (89.8%). Conclusions: Patient recruitment into the PRECISE pilot trial met our prespecified feasibility targets, and the PRECISE team is planning the larger trial.

AB - Purpose: Randomized, controlled trials of fluid resuscitation in early septic shock face many logistic challenges. We describe the Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock (PRECISE) pilot trial study design and report feasibility of patient recruitment. Materials and Methods: Six Canadian academic centers enrolled adult patients with early suspected septic shock from the emergency department and intensive care unit department. Consent was deferred. Using concealed allocation, participants were randomized to either 5% albumin or 0.9% sodium chloride. Blinded fluid resuscitation started immediately and continued for 7 days in the intensive care unit. Target recruitment was established a priori at 2 patients per site per month. Results: Fifty-one patients were enrolled; 50 patients received study fluid. We recruited a median of 2.5 patients (interquartile range [IQR], 1.5-3.0) per site per month into the trial. Median age and Acute Physiology and Chronic Health Evaluation II scores were 64.5 (IQR, 55.0-78.0) and 25.0 (IQR, 20.0-29.0), respectively. Most patients (n = 37 [74.0%]) were enrolled from the emergency department for a median of 1.6 hours (IQR, 0.8-3.5 hours) from their first hypotensive event and received a median of 2.4 L (IQR, 1.5-3.0 L) of resuscitation fluid before inclusion. Consent was deferred for 44 patients (89.8%). Conclusions: Patient recruitment into the PRECISE pilot trial met our prespecified feasibility targets, and the PRECISE team is planning the larger trial.

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Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock: A pilot randomized, controlled trial

Abstract

Bibliographical note

ASJC Scopus Subject Areas

PubMed: MeSH publication types

Access to Document

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