Fever and Antipyretic in Critically ill Evaluation :phase II randomized controlled trial (FACE II trial)
Not Applicable
Recruiting
- Conditions
- All patients admitted to intensive care with a temperature higher than 38.0 degrees C for study enrolment.
- Registration Number
- JPRN-UMIN000005593
- Lead Sponsor
- The Tokushima University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 310
Inclusion Criteria
Not provided
Exclusion Criteria
1.Acute brain injury defined as acute traumatic brain injury, subarachnoid haemorrhage, acute ischaemic stroke, acute intracerebral haemorrhage, acute intracranial infection or cardiac arrest 2.The treating clinician expects the patient to have a requirement for an analgaesic regimen containing paracetamol, NSAIDs or COX-2 inhibitors within the next 3 days. 3.Diagnosis of heat stroke, or, malignant hyperthermia, neuroleptic malignant syndrome, or other drug-induced hyperthermia, rhabdomyolysis, and thyrotoxicosis 4.Pregnancy 5.Imminent death (cardiac standstill or brain death anticipated in less than 24 hours) and the treating clinicians are not committed to full supportive care.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The principal study outcome will be whether the number of 'alive ICU-free days' measured at day 28. This outcome will be determined by the research coordinator at each participating centre. The study monitor will verify the source documentation at each monitoring visit. Alive ICU-free days is a robust outcome, and although unintended bias in outcome assessment is unlikely, this will be refined by the secondary endpoint of 'need for intensive care support'.
- Secondary Outcome Measures
Name Time Method Time without requirement for any of the following: 1. vasoactive agent 2. renal replacement therapy 3. invasive or non-invasive positive pressure ventilation