• Naomi E Hammond, Nicolai Haase, Laurent Billot, Jørn Wetterslev, Manoj K Saxena, Simon Finfer, Anders Perner, and John Myburgh.
• Critical Care and Trauma Division, The George Institute for Global Health, Sydney, NSW, Australia. nhammond@georgeinstitute.org.au.
• Crit Care Resusc. 2014 Jun 1;16(2):96-103.

BackgroundThe Crystalloid versus Hydroxyethyl Starch Trial (CHEST) and the Scandinavian Starch in Severe Sepsis/ Septic Shock (6S) trial reported that 6% hydroxyethyl starch (HES) is associated with increased use of renal replacement therapy and death in critically ill patients. Data collection was harmonised between the two trials in order to facilitate a preplanned individual patient data meta-analysis (IPDMA) of patients with severe sepsis.Objectives And RationaleTo publish a statistical analysis plan (SAP) for an IPDMA of patients with severe sepsis enrolled in the 6S trial and the CHEST.Methods And OutcomesThe SAP is described in broad detail with specific information regarding baseline characteristics and process of care. The outcomes for the trial have been described and are presented as primary, secondary and exploratory outcomes with appropriate comparisons between groups detailed. Subgroups have been defined based on pre-randomisation variables.ConclusionWe developed a preanalysis SAP to combine data on patients with severe sepsis from the 6S trial and the CHEST. Prepublication of our SAP will reduce the risk of bias in the reporting of the results and improve confidence in the estimates of effects, allowing comparisons with conventional meta-analyses and assisting in the translation of research findings into clinical practice.

This article appears in the collection: Hydroxylethyl starches: harm and acute liver injury.

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