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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
History of Changes
  Purpose

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 Intervention Phase
End-stage Chronic Renal Disease
Severe Acute Kidney Failure
Renal Transplantation
 Drug: Sevoflurane
Drug: Propofol
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 120
Study Start Date: June 2006
Study Completion Date: June 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S
General Anesthesia with sevoflurane (inhalation) as hypnotic
 Drug: Sevoflurane
General anesthesia using Sevoflurane (inhalation) as hypnotic
Active Comparator: P
General Anesthesia With Propofol TCI
 Drug: Propofol
General anesthesia with propofol TCI

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337051

Locations
France
Département d'anesthésie réanimation 1 - Hôpital Pellegrin - CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Investigators
Principal Investigator: Francois SZTARK, Pr University Hospital, Bordeaux
Study Chair: Paul PEREZ, Dr University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00337051     History of Changes
Other Study ID Numbers: 9413-04, 2003-048
Study First Received: June 14, 2006
Last Updated: June 22, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Renal transplantation
renal allograft
end-stage renal disease
renal failure
general anaesthesia
 inhaled anaesthetic
Sevoflurane
ischemia
reperfusion
ischemic lesions

Additional relevant MeSH terms:
Kidney Diseases
Acute Kidney Injury
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on May 16, 2013