Volatile Anesthetic Protection Of Renal transplants

Phase 1

Conditions: kidney transplantation
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2016-000992-26-NL

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: 520

Inclusion Criteria

Patients scheduled for kidney transplantation with a kidney from a living, 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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

high immunological risk as determined bij 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 propofol based anesthesia on acute rejection in recipients of living, DCD 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 episodes. Differences between the curves were determined with the log-rank test;Timepoint(s) of evaluation of this end point: 1 year after transplantion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Differences between groups with respect to categorical data will be tested by Chi-square or Fisher’s exact tests. Continuous data will be tested for normality with the use of Kolmogorov-Smirnov. In case of normality t-tests will be used. If not Mann-Whitney tests will be applied.. Values are given as mean with standard deviation (SD) or median with interquartile range (IQR). Regarding biomarkers, for each recipient and each biomarker an area under the curve (AUC) will be calculated. When values in the midde are missing, linear interpolation will be applied. When values at the beginning or end are missing value next in line will be used instead. When more than one value is missing in the same patient, this patient will be excluded AUC’s will be analysed with t-test or Mann-whitney<br>The repeated measurements on GFR at 1, 3, 6 and 12 months analysis will be performed using a mixed effect model<br>;Timepoint(s) of evaluation of this end point: 1 year after transplantion