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Normothermia in Patients With Acute Cerebral Damage

Normothermia in Patients With Acute Cerebral Damage

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00491192
Enrollment
Unknown
Registered
2007-06-26
Start date
2007-06-30
Completion date
2009-06-30
Last updated
2007-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage, Traumatic Brain Injury

Keywords

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

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.

Interventions

DRUGDiclofenac

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Maintenance of normothermiawithin 14 days from ICU admission

Secondary

MeasureTime frame
Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome.Within 14 days from ICU admission/Six months

Countries

Italy

Contacts

Primary ContactNino Stocchetti, MD
stocchet@policlinico.mi.it0039.02.5503.5517

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026