Volatile Anesthetic Protection Of Renal transplants
Phase 1
Active, not recruiting
- Conditions
- Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2016-000992-26-NO
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Patients scheduled for kidney transplantation with a kidney from a
DBD or DCD donor
Age > 18 years
Written informed consent
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 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 88
Exclusion Criteria
high immunological risk as determined by local practice
Patients of the ABO-incompatible program
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of a sevoflurane based anesthesia versus a<br>propofol based anesthesia on acute rejection in recipients of living, DCD<br>and DBD donor kidneys;Secondary Objective: to compare GFR on 3, 6 and 12 months between a sevoflurane based anesthesia versus a propofol based anesthesia;Primary end point(s): The Kaplan-Meier method will be used to analyze acute rejection<br>episodes. Differences between the curves were determined with the logrank<br>test;Timepoint(s) of evaluation of this end point: 1 year after transplantation
- Secondary Outcome Measures
Name Time Method