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Individual patient data comparative analysis of hydroxyethyl starch 130/0.4 v 4% albumin for fluid resuscitation in critically ill patients: Statistical analysis plan

Journal article published in 2014 by Naomi E. Hammond, Laurent Billot, Simon Finfer, John Myburgh ORCID
This paper is available in a repository.
This paper is available in a repository.

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Preprint: policy unknown
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Postprint: policy unknown
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Abstract

Recent randomised controlled trials have compared the effects of albumin and hydroxyethyl starch (HES) v crystalloids on patient-centred outcomes in critically ill patients. The Saline v Albumin Fluid Evaluation (SAFE) trial reported patient-centred outcomes at 28 days in 6933 patients assigned to fluid resuscitation with either 4% albumin or 0.9% saline; the Crystalloid v Hydroxyethyl Starch Trial (CHEST) reported patient-centred outcomes at 28 days in 6644 patients assigned to fluid resuscitation with either 6% HES (130/0.4) or 0.9% saline. As the two trials used a common reference fluid (0.9% saline) and had most trial methods and data collection points harmonised, a comparison of 4% albumin and 6% HES (130/0.4) on patient-centred outcomes at 28 days in critically ill patients using the individual patient data from the two trials is feasible.