The HEAT trial: a protocol for a multicentre randomised placebo-controlled trial of IV paracetamol in ICU patients with fever and infection
Paul J Young, 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, Mark Weatherall, Steve AR Webb, Richard W Beasley
Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine | AUSTRALASIAN MED PUBL CO LTD | Published : 2012
BACKGROUND AND OBJECTIVE: Paracetamol is commonly administered to febrile critically ill patients with infection. However, there is limited information on the efficacy and safety of using paracetamol in this setting. We describe the study protocol for a Phase IIb multicentre randomised controlled trial (the Permissive Hyperthermia Through Avoidance of Paracetamol in Known or Suspected Infection in ICU [HEAT] trial) comparing intravenous paracetamol to placebo in the treatment of fever in critically ill adults with known or suspected infection. DESIGN AND SETTING: A pilot study followed by the main trial from November 2012. 700 patients will be recruited for concealed, random, parallel assign..View full abstract
The HEAT trial is endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group, and is funded by a grant from the Health Research Council of New Zealand. All analyses and reports will be conducted independently of the funder. This study is supported by The George Institute for Global Health (Sydney, Australia), and the Medical Research Institute of New Zealand (Wellington, New Zealand).