Renal Transplantation and Inhaled Anesthetic Sevoflurane (SEVOREIN) (SévoRein)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00337051|
Recruitment Status : Completed
First Posted : June 15, 2006
Last Update Posted : June 23, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|End-stage Chronic Renal Disease Severe Acute Kidney Failure Renal Transplantation||Drug: Sevoflurane Drug: Propofol||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Sevoflurane-induced Prevention of Ischemia-reperfusion Lesions in Renal Allograft Transplants Recipients|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||June 2010|
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
- time to obtain serum creatinine levels inferior to 200µmol/l in the transplant recipient [ Time Frame: evalued at 14 days ]
- creatinemia levels at day 14 [ Time Frame: evalued at 14 days ]
- patient survival [ Time Frame: during 1 year follow-up ]
- acute rejection occurrence [ Time Frame: 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 ]
- other clinical end-points: daily diuresis, number of haemodialysis sessions [ Time Frame: during the two weeks following transplantation ]
- other biological end-points: serum creatinin and cystatinC levels [ Time Frame: during the two weeks following transplantation ]
- Other adverse events [ Time Frame: during one year folow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|