Normothermia in Patients With Acute Cerebral Damage
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|ClinicalTrials.gov Identifier: NCT00491192|
Recruitment Status : Unknown
Verified June 2007 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was: Recruiting
First Posted : June 26, 2007
Last Update Posted : September 20, 2007
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Subarachnoid Hemorrhage||Drug: Diclofenac||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Normothermia in Patients With Acute Cerebral Damage|
|Study Start Date :||June 2007|
|Study Completion Date :||June 2009|
- 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 ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491192
|Contact: Nino Stocchetti, MDemail@example.com|
|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|