End-stage Chronic Renal DiseasePhase 3SévoReinNCT00337051
Renal Transplantation and Inhaled Anesthetic Sevoflurane (SEVOREIN)
A Phase 3 study testing Sevoflurane and Propofol in people with End-stage Chronic Renal Disease and Severe Acute Kidney Failure, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Chronic Renal Disease, Severe Acute Kidney Failure, Renal Transplantation
- What is being tested?
- Sevoflurane and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2006to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Département d'anesthésie réanimation 1 - Hôpital Pellegrin - CHU de Bordeaux
Bordeaux, 33076
About this study
Official title: Sevoflurane-induced Prevention of Ischemia-reperfusion Lesions in Renal Allograft Transplants Recipients
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.
Read more
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.
Read the detailed description
Introduction :
Renal transplantation is characterized by ischemia-reperfusion lesions in allografts. Prolonged cold ischemia duration, age of donor (older than 50) or donor cardiac arrest are common factors associated with delayed graft function. In cardiac surgery, Sevoflurane (a volatile-inhaled anesthetic) protects the heart from ischemia-reperfusion lesions and preserves glomerular filtration function in patients. This cardioprotective effect involves K+-ATP mitochondrial channels which are also known to be expressed in renal cells.
Therefore, it is interesting to evaluate Sevoflurane effects in the context of renal allograft transplantation in order to shorten the delayed graft function and enhance post-operative renal function
Objectives:
Main goal:
Evaluate time necessary to obtain serum creatinine levels inferior to 200µmol/l of the recipient in the group receiving Sevoflurane in comparison with the group of patients receiving propofol infusion for general anaesthesia
Secondary goals:
- Compare serum creatinine levels in the two groups at day14
- Compare patient survival and acute rejection occurrence over a period of one-year follow-up in the two groups
- Compare the safety of both anesthetics assessed as renal tubular injury-toxicity (by measuring serum levels of NAG) and levels of serum inorganic fluor products in the post-operative period; and by referencing all adverse events
- Compare the effect of both anesthetics on delayed-recovery graft function by assessing clinical end-points (daily diuresis, number of haemodialysis sessions in the two weeks following transplantation) and biological end-points (serum creatinin and cystatinC levels in the two weeks following transplantation)
Patients:
120 patients scheduled to undergo a renal allograft transplantation with transplants defined by either a cold ischemia duration of more than 20h or a donor's age older than 50 years or a donor cardiac arrest will be randomized in 2 groups of sixty patients undergoing two different general anesthesia protocols. All patients will be included in the Renal Transplantation Unit of Bordeaux University Hospital, Aquitaine, France.
Methods:
This study will be a clinical randomized trial on 2 parallel groups. It will be double-blind for nephrologists and biologists who evaluate the end-points and will involve a population of renal transplanted patients.
The study will compare clinical and biological outcomes according to the type of general anesthesia undergone for transplantation:
- One group of patients with inhaled anesthesia by Sevoflurane (evaluated treatment)
- One group of patients with intravenous anesthesia by propofol (reference treatment).
Patients will be evaluated over a period of one year follow-up. This study is multicentric, based in Aquitaine for a period of three years, involving anaesthesiologists, nephrologists, and urologists.
Baseline brain-dead donor and graft donation characteristics will be collected by the Hospital Coordination team in Bordeaux, Pau and Bayonne.
Statistical analysis will be on intention-to-treat basis. Expected results: 1-Demonstrate Sevoflurane benefit for ischemia-reperfusion protection in renal allograft and a shortened recovery of renal graft function in the two-week post-operative period in the group allocated for Sevoflurane exposure during anaesthesia. 2-Confirm the good safety of Sevoflurane exposure in chronic end-stage renal diseased patients undergoing renal transplantation.
- Being tested
- Sevoflurane, Propofol
- Keywords
- Renal transplantation, renal allograft, end-stage renal disease, renal failure, general anaesthesia, inhaled anaesthetic, Sevoflurane, ischemia, reperfusion, ischemic lesions
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic, Renal Insufficiency, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
General anesthesia using Sevoflurane (inhalation) as hypnotic
PropofolDrug
General anesthesia with propofol TCI
| Study group | Role | What they receive |
|---|---|---|
| S | Experimental | General Anesthesia with sevoflurane (inhalation) as hypnotic Receives: Drug: Sevoflurane |
| P | Active comparator | General Anesthesia With Propofol TCI Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to obtain serum creatinine levels inferior to 200µmol/l in the transplant recipient
Measured: evalued at 14 days
Secondary outcomes (7)
creatinemia levels at day 14
Measured: evalued at 14 days
patient survival
Measured: during 1 year follow-up
acute rejection occurrence
Measured: during 1 year follow-up
safety : renal tubular injury toxicity (serum cystatinC and NAG), serum inorganic fluor products
Measured: 1, 2 and 3 days after kidney transplantation
other clinical end-points: daily diuresis, number of haemodialysis sessions
Measured: during the two weeks following transplantation
other biological end-points: serum creatinin and cystatinC levels
Measured: during the two weeks following transplantation
Other adverse events
Measured: during one year folow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionFeb 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Chronic Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Francois SZTARK, Pr, Principal investigator, University Hospital, BordeauxPaul PEREZ, Dr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337051
- Sponsor's protocol ID
- CHUBX 2004/16
- Acronym
- SévoRein
- Status last verified
- Jun 2010
- First submitted
- 14 Jun 2006
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15949912
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane-induced Prevention of Ischemia-reperfusion Lesions in Renal Allograft Transplants Recipients
- ClinicalTrials.gov ID
- NCT00337051
- Acronym / sponsor ID
- SévoRein / CHUBX 2004/16
- Keywords
- Renal transplantation, renal allograft, end-stage renal disease, renal failure, general anaesthesia, inhaled anaesthetic, Sevoflurane, ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jun 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction :
Renal transplantation is characterized by ischemia-reperfusion lesions in allografts. Prolonged cold ischemia duration, age of donor (older than 50) or donor cardiac arrest are common factors associated with delayed graft function. In cardiac surgery, Sevoflurane (a volatile-inhaled anesthetic) protects the heart from ischemia-reperfusion lesions and preserves glomerular filtration function in patients. This cardioprotective effect involves K+-ATP mitochondrial channels which are also known to be expressed in renal cells.
Therefore, it is interesting to evaluate Sevoflurane effects in the context of renal allograft transplantation in order to shorten the delayed graft function and enhance post-operative renal function
Objectives:
Main goal:
Evaluate time necessary to obtain serum creatinine levels inferior to 200µmol/l of the recipient in the group receiving Sevoflurane in comparison with the group of patients receiving propofol infusion for general anaesthesia
Secondary goals:
- Compare serum creatinine levels in the two groups at day14
- Compare patient survival and acute rejection occurrence over a period of one-year follow-up in the two groups
- Compare the safety of both anesthetics assessed as renal tubular injury-toxicity (by measuring serum levels of NAG) and levels of serum inorganic fluor products in the post-operative period; and by referencing all adverse events
- Compare the effect of both anesthetics on delayed-recovery graft function by assessing clinical end-points (daily diuresis, number of haemodialysis sessions in the two weeks following transplantation) and biological end-points (serum creatinin and cystatinC levels in the two weeks following transplantation)
Patients:
120 patients scheduled to undergo a renal allograft transplantation with transplants defined by either a cold ischemia duration of more than 20h or a donor's age older than 50 years or a donor cardiac arrest will be randomized in 2 groups of sixty patients undergoing two different general anesthesia protocols. All patients will be included in the Renal Transplantation Unit of Bordeaux University Hospital, Aquitaine, France.
Methods:
This study will be a clinical randomized trial on 2 parallel groups. It will be double-blind for nephrologists and biologists who evaluate the end-points and will involve a population of renal transplanted patients.
The study will compare clinical and biological outcomes according to the type of general anesthesia undergone for transplantation:
- One group of patients with inhaled anesthesia by Sevoflurane (evaluated treatment)
- One group of patients with intravenous anesthesia by propofol (reference treatment).
Patients will be evaluated over a period of one year follow-up. This study is multicentric, based in Aquitaine for a period of three years, involving anaesthesiologists, nephrologists, and urologists.
Baseline brain-dead donor and graft donation characteristics will be collected by the Hospital Coordination team in Bordeaux, Pau and Bayonne.
Statistical analysis will be on intention-to-treat basis. Expected results: 1-Demonstrate Sevoflurane benefit for ischemia-reperfusion protection in renal allograft and a shortened recovery of renal graft function in the two-week post-operative period in the group allocated for Sevoflurane exposure during anaesthesia. 2-Confirm the good safety of Sevoflurane exposure in chronic end-stage renal diseased patients undergoing renal transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S | Experimental | Drug: SevofluraneGeneral Anesthesia with sevoflurane (inhalation) as hypnotic |
| P | Active comparator | Drug: PropofolGeneral Anesthesia With Propofol TCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- halogenated anesthetic agent hypersensibility
- medical history or familial history of malignant hyperthermia
- porphyria
- pregnancy or breast feeding
- hyperimmunized patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneGeneral anesthesia using Sevoflurane (inhalation) as hypnotic | Drug | S |
| PropofolGeneral anesthesia with propofol TCI | Drug | P |
Primary outcome
time to obtain serum creatinine levels inferior to 200µmol/l in the transplant recipient
Time frame: evalued at 14 days
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 15949912Nouette-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois SZTARK, Pr principal investigator
University Hospital, Bordeaux
Paul PEREZ, Dr study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sevoflurane and Propofol in people with End-stage Chronic Renal Disease and Severe Acute Kidney Failure, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to obtain serum creatinine levels inferior to 200µmol/l in the transplant recipient (time frame: evalued at 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00337051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.