Clinical trial NCT02727296: Volatile Anesthetic Protection of Renal Transplants 2
Official title: Volatile Anesthetic Protection of Renal Transplants 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Delayed Graft Function
Renal Outcome After Kidney Transplantation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of a sevoflurane based anesthesia versus a propofol based anesthesia on the incidence of DGF in recipients of kidneys of donation after circulatory death (DCD) and donation after brain death (DBD) donors

Detailed description: Objective:

To compare the effect of a sevoflurane based anaesthesia versus a propofol based anaesthesia on the incidence of delayed graft function in recipients of DCD and DBD donor kidneys.

Study design:

Prospective randomized controlled European multicentre clinical trial with two parallel groups

Study population:

Patients ≥18 years scheduled for kidney transplantation with a kidney from a DBD or DCD donor

Intervention:

Patients will be included and randomised to one of the following groups:

Group 1 PROP (control): Propofol: a propofol-remifentanil based anaesthesia. Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based anaesthesia.

Main study parameters:

DGF defined as need of dialysis the first week after transplantation excluding one time dialysis for hyperkalemia Acute rejection episodes within the first year after transplantation Graft and patient survival GFR at 3 and 12 months PNF defined as a permanent lack of function of the allograft Length of hospital stay Postoperative complications of all kind kidney biomarkers (urine/plasma) mechanisms of protection/immunomodulation with anestheticanaesthetic agents

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Written informed consent

Exclusion Criteria:

* high immunological risk as determined bij local practice
* Patients of the ABO-incompatible program

Primary outcomes:
measure: incidence of delayed graft function
timeFrame: during first week after transplantation
Secondary outcomes:
measure: Glomerular Filtration Rate (GFR)
timeFrame: 3, 6 and 12 months
measure: Acute rejection
timeFrame: during first year after transplantation
measure: incidence of primary non function (PNF)
timeFrame: first three months after transplantation
measure: kidney injury urinary biomarkers
timeFrame: first week after transplantation
Other outcomes:
measure: Cardiac biomarkers in renal transplantation, Volatile vs Intravenous anesthetic agent. A substudy of the VAPOR-2 study; a multicenter randomized controlled study
timeFrame: From enrollment to 1 year follow-up
measure: Predictive value of urinary Biomarkers in a deceased donor kidney transplantation cohort to predict PNF, DGF, Acute rejection and long term graft function and outcome
timeFrame: from enrollement to follow-up of 1 year
measure: Association between intraoperative haemodynamics and vasopressor use and graft outcome
timeFrame: from enrollement to 1 year follow-up
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Oslo
country: Norway
facility: university Hospital Oslo
city: Barcelona
country: Spain
facility: Fundagio Puigvert
Study officials:
affiliation: University Medical Center Groningen
name: Gertrude J Nieuwenhuijs-Moeke, MD
role: PRINCIPAL_INVESTIGATOR
References: