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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00337051
First received: June 14, 2006
Last updated: June 22, 2010
Last verified: June 2010

June 14, 2006
June 22, 2010
June 2006
February 2010   (final data collection date for primary outcome measure)
time to obtain serum creatinine levels inferior to 200µmol/l in the transplant recipient [ Time Frame: evalued at 14 days ] [ Designated as safety issue: No ]
time to obtain serum creatinine levels inferior to 200µmol/l in the transplant recipient
Complete list of historical versions of study NCT00337051 on ClinicalTrials.gov Archive Site
  • creatinemia levels at day 14 [ Time Frame: evalued at 14 days ] [ Designated as safety issue: No ]
  • patient survival [ Time Frame: during 1 year follow-up ] [ Designated as safety issue: No ]
  • acute rejection occurrence [ Time Frame: during 1 year follow-up ] [ Designated as safety issue: No ]
  • safety : renal tubular injury toxicity (serum cystatinC and NAG), serum inorganic fluor products [ Time Frame: 1, 2 and 3 days after kidney transplantation ] [ Designated as safety issue: Yes ]
  • other clinical end-points: daily diuresis, number of haemodialysis sessions [ Time Frame: during the two weeks following transplantation ] [ Designated as safety issue: No ]
  • other biological end-points: serum creatinin and cystatinC levels [ Time Frame: during the two weeks following transplantation ] [ Designated as safety issue: No ]
  • Other adverse events [ Time Frame: during one year folow-up ] [ Designated as safety issue: Yes ]
  • creatininaemia levels at day 14
  • patient survival during 1 year follow-up
  • acute rejection occurrence during 1 year follow-up
  • safety : renal tubular injury toxicity (serum cystatinC and NAG), serum inorganic fluor products, other adverse events
  • other clinical end-points: daily diuresis, number of haemodialysis sessions in the two weeks following transplantation
  • other biological end-points: serum creatinin and cystatinC levels in the two weeks following transplantation
Not Provided
Not Provided
 
Renal Transplantation and Inhaled Anesthetic Sevoflurane (SEVOREIN)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • End-stage Chronic Renal Disease
  • Severe Acute Kidney Failure
  • Renal Transplantation
  • Drug: Sevoflurane
    General anesthesia using Sevoflurane (inhalation) as hypnotic
  • Drug: Propofol
    General anesthesia with propofol TCI
  • Experimental: S
    General Anesthesia with sevoflurane (inhalation) as hypnotic
    Intervention: Drug: Sevoflurane
  • Active Comparator: P
    General Anesthesia With Propofol TCI
    Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
June 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00337051
9413-04, 2003-048
Yes
Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
University Hospital, Bordeaux
Ministry of Health, France
Principal Investigator: Francois SZTARK, Pr University Hospital, Bordeaux
Study Chair: Paul PEREZ, Dr University Hospital, Bordeaux
University Hospital, Bordeaux
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP