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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Diclofenac

Primary Measures

• Maintenance of normothermia
  • Time Frame: within 14 days from ICU admission
    

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Fondazione Ospedale Maggiore Policlinico Milano

Overall Clinical Trial Officials and Contacts

Nino Stocchetti, MD Study Director Ospedale Maggiore Policlinico Mangiagalli e Regina Elena  

Overall Contact: Nino Stocchetti, MD 0039.02.5503.5517 stocchet@policlinico.mi.it

Information obtained from ClinicalTrials.gov on August 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00491192

Study ID Number: 1575

ClinicalTrials.gov Identifier: NCT00491192

Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health