Clinical trial NCT00491192: Normothermia in Patients With Acute Cerebral Damage
Official title: Normothermia in Patients With Acute Cerebral Damage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Traumatic Brain Injury
Subarachnoid Hemorrhage
Keywords: Fever
Acute cerebral damage
Normothermia
Diclofenac
ICU
Outcome
Intracranial pressure
Cerebral perfusion pressure
Traumatic brain injury
Subarachnoid hemorrhage
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2007-06-26
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maintenance of normothermia
timeFrame: within 14 days from ICU admission
Secondary outcomes:
measure: Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome.
timeFrame: Within 14 days from ICU admission/Six months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Study officials:
affiliation: Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
name: Nino Stocchetti, MD
role: STUDY_DIRECTOR
References: