Volatile Anesthetic Protection Of Renal Transplants 2

Study Overview
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Brief Summary
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To compare the effect of a sevoflurane based anesthesia versus a propofol based anesthesia on the incidence of DGF in recipients of kidneys of donation after circulatory death (DCD) and donation after brain death (DBD) donors

Detailed Description
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Objective: To compare the effect of a sevoflurane based anaesthesia versus a propofol based anaesthesia on the incidence of delayed graft function in recipients of DCD and DBD donor kidneys. Study design: Prospective randomized controlled European multicentre clinical trial with two parallel groups Study population: Patients ≥18 years scheduled for kidney transplantation with a kidney from a DBD or DCD donor Intervention: Patients will be included and randomised to one of the following groups: Group 1 PROP (control): Propofol: a propofol-remifentanil based anaesthesia. Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based anaesthesia. Main study parameters: DGF defined as need of dialysis the first week after transplantation excluding one time dialysis for hyperkalemia Acute rejection episodes within the first year after transplantation Graft and patient survival GFR at 3 and 12 months PNF defined as a permanent lack of function of the allograft Length of hospital stay Postoperative complications of all kind kidney biomarkers (urine/plasma) mechanisms of protection/immunomodulation with anestheticanaesthetic agents

Official Title
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Volatile Anesthetic Protection Of Renal Transplants 2

Conditions
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Delayed Graft Function, Renal Outcome After Kidney Transplantation

Intervention / Treatment
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* Drug: sevoflurane
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Written informed consent Exclusion Criteria: high immunological risk as determined bij local practice Patients of the ABO-incompatible program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol<br>Group 1 PROP (control): propofol: a propofol-remifentanil based general anesthesia. | Drug: propofol<br>* General anesthesia with propofol<br>|
| Active Comparator: sevoflurane<br>Group 2 SEVO (intervention): Sevoflurane: a sevoflurane-remifentanil based general anesthesia. | Drug: sevoflurane<br>* General anesthesia with sevoflurane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of delayed graft function | DGF is defined as need of dialysis first 7 days after transplantation | during first week after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular Filtration Rate (GFR) | GFR will be calculated with the use of a 24h creatinin clearance in urine | 3, 6 and 12 months | 
| Acute rejection | biopsy proven with decline in kidney function and therapy needed | during first year after transplantation | 
| incidence of primary non function (PNF) | PNF is defined as permanent lack of function of the transplanted kidney. This kidney will not gain function after transplantation | first three months after transplantation | 
| kidney injury urinary biomarkers | a set of kidney urinary biomarkers will be measured in urinary samples | first week after transplantation |