Permissive HyperthErmiA Through Avoidance of Paracetamol in Known or Suspected Infection in the Intensive Care Unit (ICU)

Phase 2

Completed

• Conditions: Known or suspected infection in critically ill patients in the Intensive Care Unit (ICU); Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12612000513819
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Patients are eligible to be included in the study only if they meet the following criteria at the time of randomisation:
1. Age greater than or equal to16 years
2. Standardised body temperature greater than or equal to 38.0 degrees within the previous 12 hours.
3. Receiving antimicrobial therapy for a known or suspected infection (this does NOT include post-operative patients who are receiving antibiotics for the purposes of prophylaxis rather than treatment)

Exclusion Criteria

Patients will be excluded from the study if they meet ANY of the following criteria:
1. AST or ALT greater than five times the upper limit of normal OR bilirubin greater than twice the upper limit of normal OR any other contraindication to 4gm paracetamol per day
2. a requirement for ongoing NSAID use (in excess of low dose aspirin);
3. evidence of acute brain injury during the current hospital admission (defined as any acute traumatic brain injury, subarachnoid haemorrhage, acute ischaemic stroke, acute intracerebral haemorrhage, or acute intracranial infection); hyperthermic syndromes (including heat stroke; current biochemical evidence of thyrotoxicosis (thyroid function tests are not required prior to recruitment into the trial unless clinically indicated); malignant hyperthermia, neuroleptic malignant syndrome, or other drug-induced hyperthermia)
4. admission to ICU following a cardiac arrest which is currently being treated with therapeutic hypothermia;
5. there is a limitation of therapy order or aggressive treatment is deemed unsuitable
6. patients who are moribund and, in whom, death is perceived to be imminent (within 24 hours);
7. any patient with rhabdomyolysis that is deemed by the treating clinician to be clinically significant.
8. any patient transferred from another ICU who fulfilled all inclusion criteria in the other ICU and spent >12 hours in the other ICU prior to transfer
9. any patient who is pregnant;
10. previously randomised into the HEAT trial or previously eligible for enrolment during the current ICU admission but not enrolled in the study (i.e. patients who were not enrolled within 12 hours of onset of fever in association with satisfying other eligibility criteria may not be enrolled at a later point in the ICU admission)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy measure is the number of alive ICU-free days to study day 28. The number of ICU-free days will be calculated as 28 minus the number of days in ICU (excluding days of ICU readmission). Patients who die before day 90 will be counted as having zero ICU free days.[ICU-free survival will be determined at 672 hours from the time of randomisation]