Normothermia in Patients With Acute Cerebral Damage
Recruitment status was Recruiting
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.
Traumatic Brain Injury
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Normothermia in Patients With Acute Cerebral Damage|
- Maintenance of normothermia [ Time Frame: within 14 days from ICU admission ]
- Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome. [ Time Frame: Within 14 days from ICU admission/Six months ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||June 2009|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491192
|Contact: Nino Stocchetti, MDfirstname.lastname@example.org|
|Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena||Recruiting|
|Milan, Italy, 20122|
|Sub-Investigator: Laura Ghisoni, MD|
|Principal Investigator: Katia Canavesi, MD|
|Study Director:||Nino Stocchetti, MD||Ospedale Maggiore Policlinico Mangiagalli e Regina Elena|