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Normothermia in Patients With Acute Cerebral Damage

Primary Purpose

Traumatic Brain Injury, Subarachnoid Hemorrhage

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Diclofenac

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Fever, Acute cerebral damage, Normothermia, Diclofenac, ICU, Outcome, Intracranial pressure, Cerebral perfusion pressure, Traumatic brain injury, Subarachnoid hemorrhage

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina ElenaRecruiting

Outcomes

Primary Outcome Measures

Maintenance of normothermia

Secondary Outcome Measures

Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome.

Full Information

NCT ID

NCT00491192

First Posted

June 25, 2007

Last Updated

September 19, 2007

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

1. Study Identification

Unique Protocol Identification Number

NCT00491192

Brief Title

Normothermia in Patients With Acute Cerebral Damage

Official Title

Normothermia in Patients With Acute Cerebral Damage

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Unknown status

Study Start Date

June 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury, Subarachnoid Hemorrhage

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Diclofenac

Primary Outcome Measure Information:

Title

Maintenance of normothermia

Time Frame

within 14 days from ICU admission

Secondary Outcome Measure Information:

Title

Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome.

Time Frame

Within 14 days from ICU admission/Six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nino Stocchetti, MD

Phone

0039.02.5503.5517

stocchet@policlinico.mi.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nino Stocchetti, MD

Organizational Affiliation

Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

Official's Role

Study Director

Facility Information:

Facility Name

Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

City

Milan

ZIP/Postal Code

20122

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Ghisoni, MD

First Name & Middle Initial & Last Name & Degree

Katia Canavesi, MD

12. IPD Sharing Statement

Learn more about this trial

Normothermia in Patients With Acute Cerebral Damage

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