Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337051
Status:
COMPLETED
Last Update Posted:
2010-06-23
First Post:
2006-06-14
Brief Title:
Renal Transplantation and Inhaled Anesthetic Sevoflurane SEVOREIN
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Sevoflurane-induced Prevention of Ischemia-reperfusion Lesions in Renal Allograft Transplants Recipients
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SévoRein
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
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 200µmoll 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 donors 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
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 200µmoll 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 donors 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2003-048 | None | None | None |