Normothermia in Patients With Acute Cerebral Damage

September 19, 2007 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
        • Sub-Investigator:
          • Laura Ghisoni, MD
        • Principal Investigator:
          • Katia Canavesi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maintenance of normothermia
Time Frame: within 14 days from ICU admission
within 14 days from ICU admission

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Study Director: Nino Stocchetti, MD, Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Completion

June 1, 2009

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (Estimate)

June 26, 2007

Study Record Updates

Last Update Posted (Estimate)

September 20, 2007

Last Update Submitted That Met QC Criteria

September 19, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1575

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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