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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
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Subarachnoid Hemorrhage Drug: Diclofenac Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Normothermia in Patients With Acute Cerebral Damage
Study Start Date : June 2007
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Maintenance of normothermia [ Time Frame: within 14 days from ICU admission ]

Secondary Outcome Measures :
  1. Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome. [ Time Frame: Within 14 days from ICU admission/Six months ]

Eligibility Criteria

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491192


Contacts
Contact: Nino Stocchetti, MD 0039.02.5503.5517 stocchet@policlinico.mi.it

Locations
Italy
Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Recruiting
Milan, Italy, 20122
Sub-Investigator: Laura Ghisoni, MD         
Principal Investigator: Katia Canavesi, MD         
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
Study Director: Nino Stocchetti, MD Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
More Information

ClinicalTrials.gov Identifier: NCT00491192     History of Changes
Other Study ID Numbers: 1575
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: September 20, 2007
Last Verified: June 2007

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:
Brain Injuries
Hemorrhage
Brain Injuries, Traumatic
Subarachnoid Hemorrhage
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action