Normothermia in Patients With Acute Cerebral Damage - Full Text View

Sponsor:	Fondazione Ospedale Maggiore Policlinico Milano
Information provided by:	Fondazione Ospedale Maggiore Policlinico Milano
ClinicalTrials.gov Identifier:	NCT00491192

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Normothermia in Patients With Acute Cerebral Damage

Resource links provided by NLM:

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by Fondazione Ospedale Maggiore Policlinico Milano:

Primary Outcome Measures:

Maintenance of normothermia [ Time Frame: within 14 days from ICU admission ]

Secondary Outcome Measures:

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

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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 Ospedale Maggiore Policlinico Milano

Investigators

Study Director:

Nino Stocchetti, MD

Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

More Information

No publications provided

Study ID Numbers:	1575
Study First Received:	June 25, 2007
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00491192 History of Changes
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione Ospedale Maggiore Policlinico Milano:

Fever
Acute cerebral damage
Normothermia
Diclofenac
ICU

Outcome
Intracranial pressure
Cerebral perfusion pressure
Traumatic brain injury
Subarachnoid hemorrhage

Additional relevant MeSH terms:

Craniocerebral Trauma
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Cerebrovascular Disorders
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Brain Injuries
Cyclooxygenase Inhibitors
Nervous System Diseases
Vascular Diseases
Wounds and Injuries
Central Nervous System Diseases
Diclofenac
Enzyme Inhibitors
Trauma, Nervous System
Pharmacologic Actions
Analgesics, Non-Narcotic
Subarachnoid Hemorrhage
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010