Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function

Study Overview
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Brief Summary
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The purpose of this study is to determine whether remote ischemic conditioning can improve the outcome after renal transplantation with deceased donor. Remote ischemic conditioning is performed on the patient receiving a kidney from a deceased donor. Remote ischemic conditioning is done during the operation by inflating a tourniquet on the patients leg before opening the blood circulation to the kidney. The study focus on both the immediate kidney function after the transplantation, but also on the extended kidney function one year after the transplantation.

Official Title
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Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function

Conditions
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Kidney Transplantation, Delayed Graft Function, Acute Kidney Injury, Glomerular Filtration Rate

Intervention / Treatment
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* Other: Remote ischemic conditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and above Received information, signed consent Candidate for kidney transplantation from deceased donor Exclusion Criteria: Can't give informed consent AV-fistula in the leg opposite the site where the graft will be placed Threatening ischemia in the leg If donor is a small child If the patient receives a double transplant

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non remote ischemic conditionin(non-rIC)<br>Patients receiving kidney transplantation from a deceased donor. This group does not receive remote ischemic conditioning, but has a tourniquet on the leg (not inflated). | |
| Experimental: Remote ischemic conditioning (rIC)<br>Patients receiving kidney transplantation from a deceased donor. This group receives remote ischemic conditioning by inflating a tourniquet on the leg during surgery, before reperfusion of the kidney. | Other: Remote ischemic conditioning<br>* Patients receiving kidney transplantation from a deceased donor. Remote ischemic conditioning (rIC) is done by inflating a tourniquet (250mmHg) on the patients leg before reperfusion of the kidney. The tourniquet stays on the leg on the opposite site of were the kidney is placed. rIC is done 4 x 5 min with 5 min intervals between with free blood flow.<br>* Other names: Ischemic conditioning;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to a 50% drop in baseline plasma-creatinine | Plasma-creatinine changes posttransplant will be described using an exponential/logistic/linear model depending on the individual patient data. All plasma-creatinine values 30 days posttransplant, or in case of temporary posttransplant dialysis 30 days after the last performed dialysis, will be used, measured minimum twice daily initially. Baseline plasma-creatinine is measured approximately 1 hour prior to reperfusion of the kidney. Time to a 50% drop in baseline plasma-creatinine will be estimated. | minimum 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for dialysis |  | 1 week | 
| GFR after 1 year | GFR measurement by Cr-EDTA. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal transplantation, glomerular filtration rate, remote ischemic preconditioning, remote ischemic conditioning