All patients admitted to intensive care with a temperature higher than 38.0 degrees C for study enrolment.
Conditions
Interventions
In the intensive strategy, at study entry, any antipyretics (physical cooling or medications) should be prescribed if the patient'
s core temperature is equal or greater than 38.0. Antipyretic will be stopped when core temperature is less than 37.5.
In the permissive strategy, any antipyretics (physical cooling or medications) m
s core temperature is equal or greater than 39.5. Antipyretic will be stopped when core temperature is less than 39.0.
Sponsors
The Tokushima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study if: 1.= or >20 years old 2.Patients who expected to still be ICU the day after tomorrow of randomization. 3.Patients who expected NOT to have a requirement for an analgesic regimen containing paracetamol, NSAIDs or COX-2 inhibitors within the next 3 days. 4.Patients in which body temperature (esophageal, bladder, renal, blood, tympanic membrane or axillary temperature) can be measured at least every four hourly. 5.Documented core temperature greter than 38.0 degree of Celsius in ICU (if tympanic & axillary, > 37.5 degree of Celsius)
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Time without requirement for any of the following: 1. vasoactive agent 2. renal replacement therapy 3. invasive or non-invasive positive pressure ventilation | — |
Countries
Asia(except Japan)
Contacts
Public ContactIRB
The Tokushima University Hospital IRB
Outcome results
None listed