Renal Transplantation and Inhaled Anesthetic Sevoflurane (SEVOREIN) (SévoRein)
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.
End-stage Chronic Renal Disease
Severe Acute Kidney Failure
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Sevoflurane-induced Prevention of Ischemia-reperfusion Lesions in Renal Allograft Transplants Recipients|
- 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 ]
- 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 ]
|Study Start Date:||June 2006|
|Study Completion Date:||June 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
General Anesthesia with sevoflurane (inhalation) as hypnotic
General anesthesia using Sevoflurane (inhalation) as hypnotic
Active Comparator: P
General Anesthesia With Propofol TCI
General anesthesia with propofol TCI
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337051
|Département d'anesthésie réanimation 1 - Hôpital Pellegrin - CHU de Bordeaux|
|Bordeaux, France, 33076|
|Principal Investigator:||Francois SZTARK, Pr||University Hospital, Bordeaux|
|Study Chair:||Paul PEREZ, Dr||University Hospital, Bordeaux|