Renal Transplantation and Inhaled Anesthetic Sevoflurane (SEVOREIN)

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: Ministry of Health, France
• Treatments: Anesthetics; Propofol; Sevoflurane

Criteria

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