Dantrolen as treatment for hyperthermia in patients with subarachnoidal hemorrhage

Medizin Universität Wien0 个研究点目标入组 34 人开始时间: 2007年7月10日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•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.
•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

•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

发起方

Medizin Universität Wien