Volatile Anesthetic Protection Of Renal Transplants 2

Phase 4

Completed

• Conditions: Delayed Graft Function; Patient Survival; Postoperative Complications; Renal Outcome After Kidney Transplantation; Acute Rejection (AR) of Transplanted Kidney; Primary Non Function; Graft Survival; Length of Hospital Stay
• Interventions: Drug: propofol; Drug: sevoflurane

• Registration Number: NCT02727296
• Lead Sponsor: University Medical Center Groningen

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:

Primary outcome: The two co-primary endpoints are the incidence of DGF and one-year acute rejection in recipients of DCD and DBD donor kidneys. DGF is defined as need for dialysis within the first week after transplantation, excluding one-time dialysis for hyperkalaemia. Acute rejection is defined by the modified BANFF 2013 classification and must be associated with decline in kidney function and treatment.

Secondary outcomes Functional delayed graft function (fDGF) is defined as the absence of a daily decrease of at least 10% in serum creatinine for at least three consecutive days; primary non function (PNF) defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kind (28). Estimated glomerular filtration rate (eGFR) at one week and three and twelve months calculated with the CKD-EPI formula; measured GFR employing Iodinethalamate (Groningen), CrEDTA (Aarhus) and Iohexol (Oslo) at twelve months; readmissions at three and twelve months, graft survival and patient survival at twelve months.;

The investigators predefined four substudies being: Cardiac biomarkers in renal transplantation, Volatile vs Intravenous anaesthetic agent; 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; Association between intraoperative haemodynamics and vasopressor use and graft outcome; Postoperative delirium, volatile vs Intravenous anaesthetic agent (Groningen, Aarhus);

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
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-31
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-30

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 and/or one year acute rejection	DGF: 7 days after transplantation Acute rejection: up to 1 year after transplantation	DGF is defined as need of dialysis first 7 days after transplantation Acute rejection up to 1 year after transplantation, defined by the modified BANFF 2013 classification and must be associated with decline in kidney function and treatment.

Secondary Outcome Measures

Name	Time	Method
incidence of primary non function (PNF)	up to 3 months after transplantation	PNF is defined as permanent lack of function of the transplanted kidney. This kidney will not gain function after transplantation
Estimated Glomerular Filtration Rate (GFR)	7 days after transplantation, 3 months after transplantation, 1 year after transplantation	calculated with the CKD-EPI formula
Incidence of funactional Delayed Graft Function	7 days after transplantation	Absence of a daily decrease of at least 10% in serum creatinine for at least three consecutive days
Length of hospital stay	From day of transplantation until the day of discharge, assessed up to 60 days	Days
Postoperative complications of all kind	from the day of transplantation until the day of discharge, assessed up to 60 days
hospital readmissions after transplantation	3 months after transplantation and between 3 months and 1year after transplantation
Graft survival	up to 1 year after transplantation
All-cause mortality	up to 1 year after transplantation	Mortality due to any cause
measured GFR employing Iodinethalamate (Groningen), CrEDTA (Aarhus) and Iohexol (Oslo) at twelve months	1 year after transplantation	In a subpopulation of Groningen, Aarhus, Oslo; employing Iodinethalamate (Groningen), CrEDTA (Aarhus) and Iohexol (Oslo)

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