Normothermia in Patients With Acute Cerebral Damage

Condition(s) targeted: Traumatic Brain Injury; Subarachnoid Hemorrhage

Intervention: Diclofenac (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Fondazione Ospedale Maggiore Policlinico Milano

Official(s) and/or principal investigator(s):
Nino Stocchetti, MD, Study Director, Affiliation: Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

Overall contact:
Nino Stocchetti, MD, Phone: 0039.02.5503.5517, Email: stocchet@policlinico.mi.it

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.

Official title: Normothermia in Patients With Acute Cerebral Damage

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Maintenance of normothermia

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

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.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Nino Stocchetti, MD, Phone: 0039.02.5503.5517, Email: stocchet@policlinico.mi.it

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

Starting date: June 2007
Ending date: June 2009
Last updated: September 19, 2007