Normothermia in Patients With Acute Cerebral Damage
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Traumatic Brain Injury Subarachnoid Hemorrhage |
Drug: Diclofenac |
Phase 4 |
| Study Type: | Interventional |
| 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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Nino Stocchetti, MD | 0039.02.5503.5517 | stocchet@policlinico.mi.it |
| Italy | |
| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00491192 History of Changes |
| Other Study ID Numbers: | 1575 |
| Study First Received: | June 25, 2007 |
| Last Updated: | September 19, 2007 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
|
Fever Acute cerebral damage Normothermia Diclofenac ICU |
Outcome Intracranial pressure Cerebral perfusion pressure Traumatic brain injury Subarachnoid hemorrhage |
Additional relevant MeSH terms:
|
Hemorrhage Subarachnoid Hemorrhage Brain Injuries Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Diclofenac |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013