Volatile Anesthetic Protection Of Renal transplants

Volatile Anesthetic Protection Of Renal transplants 2

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000992-26-NL

Enrollment

520

Registered

2016-05-09

Start date

2016-06-29

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney transplantation

Interventions

Trade Name: Propofol Product Name: Propofol Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: propofol CAS Number: 2078-54-8 Other descriptive name: PROPOFOL Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: high immunological risk as determined bij local practice Patients of the ABO-incompatible program

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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 The repeated measurements on GFR at 1, 3, 6 and 12 months analysis will be performed using a mixed effect model ;Timepoint(s) of evaluation of this end point: 1 year after transplantion	—

Measure

Time frame

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 The repeated measurements on GFR at 1, 3, 6 and 12 months analysis will be performed using a mixed effect model ;Timepoint(s) of evaluation of this end point: 1 year after transplantion

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Countries

Belgium, Denmark, Netherlands, Spain

Contacts

Public ContactPrinicpal investigator

unversity medical center groningen

g.j.nieuwenhuijs-moeke@umcg.nl0310503616161

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026