Traumatic Brain Injury Clinical Trial
Official title:
Normothermia in Patients With Acute Cerebral Damage
The purpose of our study is to verify wherever normothermia (achieved with diclofenac administration) may improve intracranial pressure control and may limit secondary cerebral damage thus positively influencing outcome in patients with acute cerebral damage admitted to ICU.
Pyrexia can exacerbate ischemic neuronal damage and physiological dysfunction after
traumatic brain injury and subarachnoid hemorrhage.Fever also represent an important issue
occurring in 78% of patients with acute cerebral damage admitted to intensive care unit
(ICU). For those patients, normothermia is actually recommended in order to reduce secondary
cerebral damage and to control intracranial pressure, that are known to worsen long term
prognosis. Our primary endpoint is to maintain normothermia in patients with acute cerebral
damage (axillary temperature < 38°C or internal temperature < 38,8°C) administering
diclofenac. We will also investigate the corresponding behaviour of intracranial pressure
and cerebral perfusion pressure.
Comparison(s): We will compare two different doses of subcutaneous diclofenac (0,35 mg/kg -
1/3 a vial - vs 0,5 mg/Kg - 1/2 vial) to continuous intravenous of 0,48 mg/kg diclofenac for
12 hours.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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