NCT00491192

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 20, 2007

Status Verified

June 1, 2007

First QC Date

June 25, 2007

Last Update Submit

September 19, 2007

Conditions

Traumatic Brain InjurySubarachnoid Hemorrhage

Keywords

FeverAcute cerebral damageNormothermiaDiclofenacICUOutcomeIntracranial pressureCerebral perfusion pressureTraumatic brain injurySubarachnoid hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Maintenance of normothermia

    within 14 days from ICU admission

Secondary Outcomes (1)

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

    Within 14 days from ICU admission/Six months

Interventions

DiclofenacDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with severe traumatic injury or subarachnoid hemorrhage in coma (GCS\<8), intubated, mechanically ventilated with intracranial pressure (ICP) and invasive arterial pressure monitoring

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Brain Injuries, TraumaticSubarachnoid HemorrhageFever

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsBody Temperature ChangesSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Nino Stocchetti, MD

    Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

    STUDY DIRECTOR

Central Study Contacts

Nino Stocchetti, MD

CONTACT

0039.02.5503.5517stocchet@policlinico.mi.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 26, 2007

Study Start

June 1, 2007

Study Completion

June 1, 2009

Last Updated

September 20, 2007

Record last verified: 2007-06

Locations

IT(1)