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Normothermia in Patients With Acute Cerebral Damage

NCT ID: NCT00491192

Last Updated: 2007-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury Subarachnoid Hemorrhage

Keywords

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Fever Acute cerebral damage Normothermia Diclofenac ICU Outcome Intracranial pressure Cerebral perfusion pressure Traumatic brain injury Subarachnoid hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Diclofenac

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Principal Investigators

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Nino Stocchetti, MD

Role: STUDY_DIRECTOR

Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

Locations

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Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Nino Stocchetti, MD

Role: CONTACT

Phone: 0039.02.5503.5517

Email: [email protected]

Other Identifiers

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1575

Identifier Type: -

Identifier Source: org_study_id