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Normothermia in Patients With Acute Cerebral Damage

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00491192
First Posted: June 26, 2007
Last Update Posted: September 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
June 25, 2007
June 26, 2007
September 20, 2007
June 2007
Not Provided
Maintenance of normothermia [ Time Frame: within 14 days from ICU admission ]
Same as current
Complete list of historical versions of study NCT00491192 on ClinicalTrials.gov Archive Site
Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome. [ Time Frame: Within 14 days from ICU admission/Six months ]
Same as current
Not Provided
Not Provided
 
Normothermia in Patients With Acute Cerebral Damage
Normothermia in Patients With Acute Cerebral Damage
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Traumatic Brain Injury
  • Subarachnoid Hemorrhage
Drug: Diclofenac
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
Not Provided
June 2009
Not Provided

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00491192
1575
No
Not Provided
Not Provided
Not Provided
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Not Provided
Study Director: Nino Stocchetti, MD Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP