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

University of Aarhus220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

220

Conditions

Kidney Transplantation Delayed Graft Function Acute Kidney Injury Glomerular Filtration Rate

Remote ischemic conditioningOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Dept. of Renal Medicine, Aarhus University Hospital, Skejby

Aarhus N, Denmark

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Division of Transplant Surgery, Erasmus MC, University Medical Center

Rotterdam, Rotterdam, Netherlands

Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg

Gothenburg, Sweden

Outcomes

Primary Outcomes

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.

Time frame: minimum 1 week

Secondary Outcomes

Need for dialysis

Time frame: 1 week

GFR after 1 year

GFR measurement by Cr-EDTA.

Time frame: 12 months