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

Not Applicable

• Conditions: Acute Kidney Injury; Delayed Graft Function; Kidney Transplantation; Glomerular Filtration Rate
• Interventions: Other: Remote ischemic conditioning

• Registration Number: NCT01395719
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-15
• Primary Completion: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Age 18 and above
• Received information, signed consent
• Candidate for kidney transplantation from deceased donor

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote ischemic conditioning (rIC)	Remote ischemic conditioning	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.

Primary Outcome Measures

Name	Time	Method
Time to a 50% drop in baseline plasma-creatinine	minimum 1 week	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.

Secondary Outcome Measures

Name	Time	Method
GFR after 1 year	12 months	GFR measurement by Cr-EDTA.
Need for dialysis	1 week

Trial Locations

Locations (4)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Division of Transplant Surgery, Erasmus MC, University Medical Center; 🇳🇱 Rotterdam, Netherlands

Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg; 🇸🇪 Gothenburg, Sweden

Dept. of Renal Medicine, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus N, Denmark