Normothermia in Patients With Acute Cerebral Damage

Phase 4

• Conditions: Subarachnoid Hemorrhage; Traumatic Brain Injury

• Registration Number: NCT00491192
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

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

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.

Study Timeline

• Status Verified: 2007-06
• Study Start: 2007-06
• Study First Submitted: 2007-06-25
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-26
• Last Update Submitted: 2007-09-19
• Last Update Posted: 2007-09-20
• Study Completion: 2009-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maintenance of normothermia	within 14 days from ICU admission

Secondary Outcome Measures

Name	Time	Method
Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome.	Within 14 days from ICU admission/Six months

Trial Locations

Locations (1)

Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena; 🇮🇹 Milan, Italy