ACTRN12612000513819
Completed
Phase 2
A phase 2b randomised controlled trial investigating the safety and efficacy of intravenous paracetamol versus placebo (5% dextrose) in the treatment of fever in critically ill patients with known or suspected infection.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Known or suspected infection in critically ill patients in the Intensive Care Unit (ICU)
- Sponsor
- Medical Research Institute of New Zealand
- Enrollment
- 700
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Not specified
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