Normothermia in Patients With Acute Cerebral Damage
Recruitment status was Recruiting
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 25, 2007 | ||||
| Last Updated Date | September 19, 2007 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Maintenance of normothermia [ Time Frame: within 14 days from ICU admission ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00491192 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome. [ Time Frame: Within 14 days from ICU admission/Six months ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Normothermia in Patients With Acute Cerebral Damage | ||||
| Official Title ICMJE | Normothermia in Patients With Acute Cerebral Damage | ||||
| Brief 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. |
||||
| Detailed 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Drug: Diclofenac | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00491192 | ||||
| Other Study ID Numbers ICMJE | 1575 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | ||||
| Verification Date | June 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||