Renal Transplantation and Inhaled Anesthetic Sevoflurane (SEVOREIN)

Study acronym: SévoRein
StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Study Identification, Study Status, Sponsor/Collaborators, Referencesv7
  2. Trial status: Recruiting to Completed
    • Study completion date changed from estimate of Feb 2010 to Jun 2010
    • Site details revised
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Primary completion date: Feb 2010v4 Show 5 more changesShow less
    • Study completion date: Jul 2009 to Feb 2010
    • Interventions: Sevoflurane (Drug), propofol (Drug) to Propofol (Drug), Sevoflurane (Drug)
    • Secondary endpoints: 6 to 7
    • Site contact updated
    • Study arms: 0 to 2
  5. Study completion date: Jul 2009
    • Secondary endpoints revised (6)
    v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Jun 2006
    • Secondary endpoints revised (6)
    • Site details revised
    • Eligibility criteria expanded, about 3 words
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00337051
Lead Sponsor University Hospital, Bordeaux
Collaborators: Ministry of Health, France
Conditions
(from sponsor)		 End-stage Chronic Renal Disease, Severe Acute Kidney Failure, Renal Transplantation
Related terms Acute Kidney Injury, Ischemia, Kidney Failure, Chronic, Renal Insufficiency
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov