• Paul J Young, Mark Weatherall, Manoj K Saxena, Rinaldo Bellomo, Ross C Freebairn, Naomi E Hammond, Frank Mp van Haren, Seton J Henderson, Colin J McArthur, Shay P McGuinness, Diane Mackle, John A Myburgh, Steve A R Webb, Richard W Beasley, and Australian and New Zealand Intensive Care Society Clinical Trials Group.
• Intensive Care Unit, Wellington Regional Hospital, Wellington, New Zealand.
• Crit Care Resusc. 2013 Dec 1;15(4):279-86.

Background And ObjectiveWe describe the statistical analysis plan (SAP) for the Permissive Hyperthermia through Avoidance of Paracetamol in Known or Suspected Infection in the Intensive Care Unit (HEAT) trial, a 700-patient, prospective, randomised, Phase 2b, multicentre, double-blind, parallel-groups, placebo-controlled trial of paracetamol administration for the treatment of fever in critically ill patients with known or suspected infection.MethodsThe data fields described are those outlined in the study protocol published previously. We describe the plan for the presentation and comparison of baseline characteristics, process measures and outcomes. We describe baseline characteristics, and define and categorise trial outcomes according to their assigned importance.Results And ConclusionsWe developed an SAP for the HEAT trial, and produced a mock Consolidated Standards of Reporting Trials diagram and tables. Our prespecified SAP accords with high-quality standards of internal validity and should minimise future analysis bias.

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