Dantrolen as treatment for hyperthermia in patients with subarachnoidal hemorrhage

• Conditions: Fever episodes occur in more than 50%of patients with subarachnoidal hemorrhage despite antibiotic and antipyretic therapy.The exact mechanism of hyperthermia-induced brain injury is not known. Hyperthermia might increase the release of excitatory neurotransmitters or trigger an amount of oxygen free radicals. Hyperthermia may also aggravate blood-brain barrier disruption.The deleterious effect of fever has been demonstrated in patients with subarachnoidal hemorrhage.; MedDRA version: 9.1Level: LLTClassification code 10020846Term: Hyperthermia therapy

• Registration Number: EUCTR2007-003232-35-AT
• Lead Sponsor: Medizin Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-10
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

The study will be restricted to neurosurgical patients after subarachnoidal hemorrhage aged from 18 to 80 years.
There will be no limitation of enrollment as to patients breathing spontaneously or being ventilator dependant.
AND
sustained fever (=38ºC for more than an hour) without an identifiable infectious cause.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients who, in the judgment of the attending anesthesiologist, have active infection likely to cause fever. The judgment will be based on the following evidence collected within 24 hours of study enrollment: white blood cell count above 12,000 c/dL, opacities in chest x-rays, sputum containing pus from visual exam, or positive cultures of sputum, blood, or urine.
•Pregnancy determined by giving a urine pregnancy test immediately before consent is obtained. Female patients less than 50 years of age will undergo a pregnancy test unless there is a history of previous hysterectomy.
•Patients who have been diagnosed with arrhythmia within 24 hours of study enrollment
•Patients with a history of muscular dystrophy
•Patients in whom the dose of mannitol for treatment or placebo groups is contraindicated by having increased serum osmolarity (> 320 mOsmol/L) as measured immediately following signature of informed consent. Hypotension will not be an issue because all neuro intensive care patients are kept at least normotensive using fluid or vasopressors if indicated.
•Patients who are known to have acute liver disease at the time of study enrollment as shown by the most recent lab tests available within 72 hours of screening. If appropriate tests are not available , they will be performed after informed consent is obtained. The tests are as follows: ALT> 94 u/L, AST > 120 u/L.
•Patients who have stage 2 cirrhosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified