Renal Transplantation and Inhaled Anesthetic Sevoflurane (SEVOREIN) (SévoRein)

May 11, 2026 updated by: University Hospital, Bordeaux

Sevoflurane-induced Prevention of Ischemia-reperfusion Lesions in Renal Allograft Transplants Recipients

Renal transplantation is characterized by ischemia-reperfusion lesions in allograft. In a previous study, Julier and al. (Anesthesiology 2003) have demonstrated that sevoflurane reduces glomerular lesions in kidney of patients undergoing a cardiovascular surgery and présenting with ischemia-reperfusion phenomena.

The purpose of the study is to evaluate the effects of sevoflurane on the recovery of renal graft function in patients after kidney transplantation.

This study will be a randomized, double blinded, controlled clinical trial and 120 patients undergoing renal allograft transplantation will be included.

Patients will be divided into 2 groups: one group of patients who will receive sevoflurane (evaluated treatment) for anaesthesia and the other one who will receive propofol (reference treatment).

We will evaluate renal function for one year after transplantation. Ours results will confirm or not that sevoflurane protects kidney function from ischemia-reperfusion lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction :

Renal transplantation is characterized by ischemia-reperfusion lesions in allografts. Prolonged cold ischemia duration, age of donor (older than 50) or donor cardiac arrest are common factors associated with delayed graft function. In cardiac surgery, Sevoflurane (a volatile-inhaled anesthetic) protects the heart from ischemia-reperfusion lesions and preserves glomerular filtration function in patients. This cardioprotective effect involves K+-ATP mitochondrial channels which are also known to be expressed in renal cells.

Therefore, it is interesting to evaluate Sevoflurane effects in the context of renal allograft transplantation in order to shorten the delayed graft function and enhance post-operative renal function

Objectives:

Main goal:

Evaluate time necessary to obtain serum creatinine levels inferior to 200µmol/l of the recipient in the group receiving Sevoflurane in comparison with the group of patients receiving propofol infusion for general anaesthesia

Secondary goals:

  • Compare serum creatinine levels in the two groups at day14
  • Compare patient survival and acute rejection occurrence over a period of one-year follow-up in the two groups
  • Compare the safety of both anesthetics assessed as renal tubular injury-toxicity (by measuring serum levels of NAG) and levels of serum inorganic fluor products in the post-operative period; and by referencing all adverse events
  • Compare the effect of both anesthetics on delayed-recovery graft function by assessing clinical end-points (daily diuresis, number of haemodialysis sessions in the two weeks following transplantation) and biological end-points (serum creatinin and cystatinC levels in the two weeks following transplantation)

Patients:

120 patients scheduled to undergo a renal allograft transplantation with transplants defined by either a cold ischemia duration of more than 20h or a donor's age older than 50 years or a donor cardiac arrest will be randomized in 2 groups of sixty patients undergoing two different general anesthesia protocols. All patients will be included in the Renal Transplantation Unit of Bordeaux University Hospital, Aquitaine, France.

Methods:

This study will be a clinical randomized trial on 2 parallel groups. It will be double-blind for nephrologists and biologists who evaluate the end-points and will involve a population of renal transplanted patients.

The study will compare clinical and biological outcomes according to the type of general anesthesia undergone for transplantation:

  • One group of patients with inhaled anesthesia by Sevoflurane (evaluated treatment)
  • One group of patients with intravenous anesthesia by propofol (reference treatment).

Patients will be evaluated over a period of one year follow-up. This study is multicentric, based in Aquitaine for a period of three years, involving anaesthesiologists, nephrologists, and urologists.

Baseline brain-dead donor and graft donation characteristics will be collected by the Hospital Coordination team in Bordeaux, Pau and Bayonne.

Statistical analysis will be on intention-to-treat basis. Expected results: 1-Demonstrate Sevoflurane benefit for ischemia-reperfusion protection in renal allograft and a shortened recovery of renal graft function in the two-week post-operative period in the group allocated for Sevoflurane exposure during anaesthesia. 2-Confirm the good safety of Sevoflurane exposure in chronic end-stage renal diseased patients undergoing renal transplantation.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Département d'anesthésie réanimation 1 - Hôpital Pellegrin - CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age > 18 years
  • scheduled to undergo renal allograft transplantation
  • transplant : cold ischemia duration > 20 hours or donor age > 50 years or donor cardiac arrest
  • ASA 2-3
  • social security affiliation
  • informed consent signed

Exclusion Criteria:

  • halogenated anesthetic agent hypersensibility
  • medical history or familial history of malignant hyperthermia
  • porphyria
  • pregnancy or breast feeding
  • hyperimmunized patient
  • participation in an immunosuppressive drug trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S
General Anesthesia with sevoflurane (inhalation) as hypnotic
Drug: Sevoflurane
General anesthesia using Sevoflurane (inhalation) as hypnotic
Active Comparator: P
General Anesthesia With Propofol TCI
Drug: Propofol
General anesthesia with propofol TCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to obtain serum creatinine levels inferior to 200µmol/l in the transplant recipient
Time Frame: evalued at 14 days
evalued at 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
creatinemia levels at day 14
Time Frame: evalued at 14 days
evalued at 14 days
patient survival
Time Frame: during 1 year follow-up
during 1 year follow-up
acute rejection occurrence
Time Frame: during 1 year follow-up
during 1 year follow-up
safety : renal tubular injury toxicity (serum cystatinC and NAG), serum inorganic fluor products
Time Frame: 1, 2 and 3 days after kidney transplantation
1, 2 and 3 days after kidney transplantation
other clinical end-points: daily diuresis, number of haemodialysis sessions
Time Frame: during the two weeks following transplantation
during the two weeks following transplantation
other biological end-points: serum creatinin and cystatinC levels
Time Frame: during the two weeks following transplantation
during the two weeks following transplantation
Other adverse events
Time Frame: during one year folow-up
during one year folow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Francois SZTARK, Pr, University Hospital, Bordeaux
  • Study Chair: Paul Perez, Dr, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 14, 2006

First Submitted That Met QC Criteria

June 14, 2006

First Posted (Estimated)

June 15, 2006

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2004/16
  • 2003-048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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