NCT00337051

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

May 14, 2026

Status Verified

June 1, 2010

Enrollment Period

3.7 years

First QC Date

June 14, 2006

Last Update Submit

May 11, 2026

Conditions

End-stage Chronic Renal DiseaseSevere Acute Kidney FailureRenal Transplantation

Keywords

Renal transplantationrenal allograftend-stage renal diseaserenal failuregeneral anaesthesiainhaled anaestheticSevofluraneischemiareperfusionischemic lesions

Outcome Measures

Primary Outcomes (1)

  • time to obtain serum creatinine levels inferior to 200µmol/l in the transplant recipient

    evalued at 14 days

Secondary Outcomes (7)

  • creatinemia levels at day 14

    evalued at 14 days

  • patient survival

    during 1 year follow-up

  • acute rejection occurrence

    during 1 year follow-up

  • safety : renal tubular injury toxicity (serum cystatinC and NAG), serum inorganic fluor products

    1, 2 and 3 days after kidney transplantation

  • other clinical end-points: daily diuresis, number of haemodialysis sessions

    during the two weeks following transplantation

  • +2 more secondary outcomes

Study Arms (2)

S

EXPERIMENTAL

General Anesthesia with sevoflurane (inhalation) as hypnotic

Drug: Sevoflurane

P

ACTIVE COMPARATOR

General Anesthesia With Propofol TCI

Drug: Propofol

Interventions

SevofluraneDRUG

General anesthesia using Sevoflurane (inhalation) as hypnotic

S
PropofolDRUG

General anesthesia with propofol TCI

P

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département d'anesthésie réanimation 1 - Hôpital Pellegrin - CHU de Bordeaux

Bordeaux, 33076, France

Location

Related Publications (1)

  • Nouette-Gaulain K, Lemoine P, Cros AM, Sztark F. [Induction of anaesthesia with target-controlled inhalation of sevoflurane in adults with the ZEUS anaesthesia machine]. Ann Fr Anesth Reanim. 2005 Jul;24(7):802-6. doi: 10.1016/j.annfar.2005.04.029. French.

    PMID: 15949912RESULT

MeSH Terms

Conditions

Acute Kidney InjuryKidney Failure, ChronicRenal InsufficiencyIschemia

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Francois SZTARK, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Paul PEREZ, Dr

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 15, 2006

Study Start

June 1, 2006

Primary Completion

February 1, 2010

Study Completion

June 1, 2010

Last Updated

May 14, 2026

Record last verified: 2010-06

Locations

FR(1)