Volatile Anesthetic Protection of Renal Transplants 2

Phase 4

Completed

• Conditions: Delayed Graft Function; Renal Outcome After Kidney Transplantation
• Interventions: Drug: propofol; Drug: sevoflurane

• Registration Number: NCT02727296
• Lead Sponsor: Gertrude J. Nieuwenhuijs-Moeke, MD PhD

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

Study Timeline

• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-04-01
• Study First Posted: 2016-04-04
• Study Start: 2017-04-01
• Status Verified: 2024-01
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-31
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

Inclusion Criteria

• Age > 18 years
• Written informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol	propofol	Group 1 PROP (control): propofol: a propofol-remifentanil based general anesthesia.
sevoflurane	sevoflurane	Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based general anesthesia.

Primary Outcome Measures

Name	Time	Method
incidence of delayed graft function	during first week after transplantation	DGF is defined as need of dialysis first 7 days after transplantation

Secondary Outcome Measures

Name	Time	Method
kidney injury urinary biomarkers	first week after transplantation	a set of kidney urinary biomarkers will be measured in urinary samples
Glomerular Filtration Rate (GFR)	3, 6 and 12 months	GFR will be calculated with the use of a 24h creatinin clearance in urine
Acute rejection	during first year after transplantation	biopsy proven with decline in kidney function and therapy needed
incidence of primary non function (PNF)	first three months after transplantation	PNF is defined as permanent lack of function of the transplanted kidney. This kidney will not gain function after transplantation

Trial Locations

Locations (5)

Amsterdam University Medical Center; 🇳🇱 Amsterdam, Netherlands

university Hospital Oslo; 🇳🇴 Oslo, Norway

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Fundagio Puigvert; 🇪🇸 Barcelona, Spain