Normothermia in Patients With Acute Cerebral Damage

Traumatic Brain Injury Clinical Trial

Official title:

Normothermia in Patients With Acute Cerebral Damage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00491192
• Other study ID #: 1575
• Status: Recruiting
• Phase: Phase 4
• First received: June 25, 2007
• Last updated: September 19, 2007
• Start date: June 2007
• Est. completion date: June 2009

Study information

• Verified date: June 2007
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Nino Stocchetti, MD
• Phone: 0039.02.5503.5517
• Email: stocchet[@]policlinico.mi.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Hemorrhage
• Subarachnoid Hemorrhage
• Traumatic Brain Injury

Intervention

Drug:
• Diclofenac

Locations

Country	Name	City	State
Italy	Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of normothermia		within 14 days from ICU admission
Secondary	Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome.		Within 14 days from ICU admission/Six months