ActivePhase 2Phase 3ACTRN12611000981921

Permissive HyperthErmia Through Avoidance of Paracetamol in Known or Suspected Infection in the Intensive Care Unit (ICU) - pilot study

A Pilot randomised controlled trial investigating the safety and efficacy of a permissive temperature strategy against a paracetamol-based strategy in critically ill patients with known or suspected infection


Sponsor

Medical Research Institute of New Zealand

Enrollment

30 participants

Start Date

Mar 29, 2012

Study Type

Interventional

Conditions

Summary

Fever is an adaptive response to infections which occurs widely in the animal kingdom. The suppression of fever increases the risk of mortality in animals, although the effect of antipyretics in critically ill patients is unknown. The objective of this study is to determine whether paracetamol influences the risk of mortality in critically ill patients with fever and known or suspected infection. A phase 2b double blind randomised placebo controlled trial of paracetamol will be undertaken in 700 patients with fever and known or suspected infection in New Zealand and Australia under the auspices of the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG). If either the aggressive or permissive antipyretic regimes influence outcomes including survival in patients with fever and infection, the findings will have a major impact on the burden of infectious disease in New Zealand and internationally.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

The HEAT trial investigates whether allowing fever to run its course in ICU patients with infections (by avoiding paracetamol) improves outcomes compared with actively treating the fever. It includes patients aged 16 and older who have a temperature of 38 degrees or higher and are receiving antibiotics for a known or suspected infection.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

After randomisation, the patient will receive 1gm of IV paracetamol or placebo 6 hourly until one of the following occurs: 1. the patient ceases antimicrobial therapy 2. the patient is discharged fr

After randomisation, the patient will receive 1gm of IV paracetamol or placebo 6 hourly until one of the following occurs: 1. the patient ceases antimicrobial therapy 2. the patient is discharged from ICU 3. the patient is deemed to have completed the course of study medication (as described below) Provided that the patient remains on antimicrobial therapy and remains in ICU, they will receive paracetamol or placebo until at least the morning of study day 2. On the morning of study day 2, the research co-ordinator will assess the patient. If the patient has not had a standardised body temperature of <37.5 degrees for the previous 24 hours, they will continue to receive paracetamol or placebo 6 hourly and will be assessed by the research co-ordinator on each subsequent morning to determine if they have had a standardised body temperature of <37.5 degrees for the previous 24 hours. If, at the time of assessment by the research co-ordinator, the patient has had a standardised body temperature of <37.5 degrees for the entire past 24 hours, further study treatment will be withheld. If the patient does not develop a fever of >37.9 degrees within 48 hours from the time of assessment by the research co-ordinator, they will be deemed to have completed the course of study medication. If the patient does develop another standardised body temperature of >37.9 degrees , the patient will restart study medication and, thereafter, they will be assessed each morning by the research co-ordinator to determine whether they a have had a standardised body temperature of <37.5 degrees for a period of 24 hours at which point medication will be withheld and then stopped as described above. Once the patient has completed the course of study medication, they may receive open label paracetamol at the discretion of the treating clinician.


Locations(1)

New Zealand

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ACTRN12611000981921