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

Medical Research Institute of New Zealand0 sites30 target enrollmentSeptember 14, 2011

Overview

No summary available.

Registry

who.int

Start Date

September 14, 2011

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•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)

•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;