Renal Transplantation and Inhaled Anesthetic Sevoflurane (SEVOREIN)
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.
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
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Conditions
End-stage Chronic Renal Disease
Intervention
Sevoflurane, Propofol
Location
Département d'anesthésie réanimation 1 - Hôpital Pellegrin - CHU de Bordeaux
Bordeaux
France
33076
Status
Completed
Source
University Hospital, Bordeaux
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00337051
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Renal Insufficiency, Chronic
Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)
Kidney Failure, Chronic
The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.
Propofol
An intravenous anesthetic agent which has the advantage of a very rapid onset after infusion or bolus injection plus a very short recovery period of a couple of minutes. (From Smith and Reynard, Textbook of Pharmacology, 1992, 1st ed, p206). Propofol has been used as ANTICONVULSANTS and ANTIEMETICS.
Disease Progression
The worsening of a disease over time. This concept is most often used for chronic and incurable diseases where the stage of the disease is an important determinant of therapy and prognosis.
Bronchitis, Chronic
A subcategory of CHRONIC OBSTRUCTIVE PULMONARY DISEASE. The disease is characterized by hypersecretion of mucus accompanied by a chronic (more than 3 months in 2 consecutive years) productive cough. Infectious agents are a major cause of chronic bronchitis.
Clinical Trials
Comparison of Sevoflurane, Propofol, and Sevoflurane Plus Propofol for Maintenance of Anaesthesia
Postoperative pain may be affected by general anaesthetics. The effect of propofol and sevoflurane on postoperative pain in chinese female patients has not been demonstrated before. This s...
Inhalative Sedation in ICU With Sevoflurane Via Anaesthetic Conserving Device Compared to Propofol
The evaluation of the presented study will work on the practicability of inhalative sedation on the ICU, potential benefits and limitations of the ACD system in a postoperative sedated pat...
Propofol Versus Volatile Anesthesia in Post Operative Pain Management
The study will test the hypothesis that patients anesthetized with propofol suffer less postoperative pain than those anesthetized with sevoflurane.
COGNITIVE - Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-Heart Operations
The aim of the study is to prove whether general anesthesia with inhaled sevoflurane reduces the frequency of neurological and cognitive impairment after open-heart operations with use of...
Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care
Endotracheal intubation is a painful and stressful procedure, which is associated with acute increases of blood pressure, intracranial pressure, bradycardia and hypoxemia with high morbidi...
PubMed Articles
Sevoflurane, one of the most commonly used inhalation anesthetics, induces apoptosis and oxidative stress in lymphocytes. Propofol, an intravenous anesthetic, exhibits antiapoptotic and antioxidative...
Effects of sevoflurane and propofol on cultured bone-marrow mesenchymal stem cells of rats.
Objective: Bone marrow mesenchymal stem cell (BMSC) is a potentially effective vehicle for the cell and gene therapy in clinical disease treatment. We studied whether the most commonly used anesthetic...
Background: In this study, we compared liver function tests after hepatectomy with inflow occlusion as a function of propofol versus sevoflurane anesthesia. Methods: One hundred patients undergoing el...
This prospective randomised study compared the antitussive effect of remifentanil during recovery from either propofol or sevoflurane anaesthesia. Seventy-four female patients undergoing thyroidectomy...
Sevoflurane to alleviate pain on propofol injection.
PURPOSE: Since the introduction of propofol, several drugs and methods have been used to alleviate the pain on its injection. This study was designed to evaluate the effect of adding sevoflurane 3% du...
