Normothermia in Patients With Acute Cerebral Damage

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Normothermia in Patients With Acute Cerebral Damage

Conditions
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Traumatic Brain Injury, Subarachnoid Hemorrhage

Intervention / Treatment
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* Drug: Diclofenac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with severe traumatic injury or subarachnoid hemorrhage in coma (GCS<8), intubated, mechanically ventilated with intracranial pressure (ICP) and invasive arterial pressure monitoring Exclusion Criteria: Know adverse reactions with NSAI Platelets count < 20,000/dl Gastric or duodenal ulceration in active phase Hepatic insufficiency, cirrhosis or previous liver transplant Acute or chronic renal insufficiency Coronary insufficiency, acute myocardial infarct in the previous 6 month Barbiturate coma Patients in therapy with acetylsalicylic acid, lithium, digoxin, methotrexate and cyclosporin. Known or suspected pregnancy

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Diclofenac|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of normothermia |  | within 14 days from ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome. |  | Within 14 days from ICU admission/Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fever, Acute cerebral damage, Normothermia, Diclofenac, ICU, Outcome, Intracranial pressure, Cerebral perfusion pressure, Traumatic brain injury, Subarachnoid hemorrhage