The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether upper limb ischemic postconditioning can improve renal function and decrease ischemic-reperfusion injury in patients undergoing living donor kidney transplantation.

Detailed Description
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Ischemic reperfusion injury after kidney transplantation is a common clinical problem associated with a high morbidity and mortality. To reduce the adverse effect of ischemic reperfusion injury after organ transplantation, various strategies including ischemic preconditioning or postconditioning. Remote ischemic postconditioning is one of such strategies where brief ischemic reperfusion injury of one organ protects other organs from sustained ischemic reperfusion injury. Remote ischemic postconditioning of the limb with a tourniquet is a safe and convenient method of postconditioning organs against ischemic reperfusion injury. However, the efficacy of remote ischemic postconditioning in patients undergoing living donor kidney transplantation needs to be established. Therefore, we investigate the efficacy of remote ischemic postconditioning of the upper limb with a tourniquet in recipients of kidney transplantation by measuring the markers of acute kidney injury.

Official Title
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The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation

Conditions
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Kidney Transplantation, Ischemic Reperfusion Injury, Remote Ischemic Postconditioning

Intervention / Treatment
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* Device: remote ischemic postconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects undergoing elective living donor kidney transplantation subjects older than 20 yrs who can give written informed consent Exclusion Criteria: re-transplant recipients those with peripheral vascular disease affecting the upper limbs free of arteriovenous fistula

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Remote ischemic postconditioning group<br>Recipients receive remote ischemic postconditioning after declamping of renal artery during kidney transplantation | Device: remote ischemic postconditioning<br>* Remote ischemic postconditioning consists of three 5-min cycles of upper limb ischemia, which was induced by an automated cuff-inflator placed on the upper limb free of arteriovenous fistula and inflated to 250 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.<br>|
| No Intervention: Control group<br>Patients who have a deflated cuff placed on the upper limb free of arteriovenous fistula during the surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function of recipient after living-related kidney transplantation | serum creatinine concentration and urine output | 1 day before surgery | 
| renal function of recipient after living-related kidney transplantation | serum creatinine concentration and urine output | at 2 h after declaming of renal artery | 
| renal function of recipient after living-related kidney transplantation | serum creatinine concentration and urine output | at 6 h after declaming of renal artery | 
| renal function of recipient after living-related kidney transplantation | serum creatinine concentration and urine output | at 12 h after declaming of renal artery | 
| renal function of recipient after living-related kidney transplantation | serum creatinine concentration and urine output | at 24 h after declaming of renal artery | 
| renal function of recipient after living-related kidney transplantation | serum creatinine concentration and urine output | at 48 h after declaming of renal artery | 
| renal function of recipient after living-related kidney transplantation | serum creatinine concentration and urine output | at 72 h after declaming of renal artery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of acute kidney injury | biomarkers of acute kidney injury: Plasma cystatin-C, Urine IL-18, Urine Neutrophil gelatinase-associated lipocalin (NGAL) | before surgery and at 2, 6, 12 h after declaming of renal artery | 
| Hemodynamic parameters | arterial blood pressure, heart rate, central venous pressure, pulse oximetry | before surgery and at 2, 6, 12, 24, 48, 72 h after declaming of renal artery | 
| outcome of kidney transplantation | number of acute rejection or number of delayed graft function | at 72 h after declaming of renal artery | 
| postoperative hospital stay | length of postoperative hospital stay (days) | at postoperative day 60 |