The influence of cooling patients to <34 degrees celsius, which is commonly performed after successful cardiopulmonary resuscitation, on the metabolism of various drugs commonly used in that clinical situation.
- Conditions
- Patients after successful cardiopulmonary resuscitation who undergo target temperature management for 24h hoursTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2018-002226-22-AT
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
•Successful cardiopulmonary resuscitation (CPR) and target temperature management <34°C
•>18 years of age
• planned treatment with erythromycin, paracetamol, pantoprazole
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 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26
•Increased inflammatory biomarkers at admission (C-reactive protein>5mg/dL), if available
•Expected life expectancy <3 days
•Patients with esophageal temperature <34.0°C at admission
•Known liver dysfunction (i.e. liver cirrhosis, history of significant liver disorders)
•Chronic kidney failure
•Intake of known inducers or inhibitors of CYP2C19 or CYP3A4
•Allergies of intolerances against any of the trial related substances
•Prior erythromycin, pantoprazole or paracetamol treatment within 24 hours
•Treatment with ciclosporin, tacrolimus, sirolimus, indinavir, ritonavir, saquinavir, or other drugs deemed relevant by the treating physician
•Pregnancy or breastfeeding
•Erythromycin: ongoing rhythm disturbances, such as ventricular tachycardias or ventricular fibrilliation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method