Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

Study Overview
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Brief Summary
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The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation

Detailed Description
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Ischemia reperfusion injury (IRI) induced renal failure after kidney transplantation is a common clinical problem associated with a high morbidity and mortality. To reduce the adverse effects of IRI after organ transplantation various strategies aimed at the different pathophysiological processes of IRI have been investigated. Remote ischemic preconditioning (RIPC) is one such strategy where brief IRI of one organ protects other organs from sustained IRI. Many studies have shown that RIPC protects heart, muscle flaps, stomach, liver, lungs, and kidneys from IRI. RIPC of the limb with a tourniquet is a safe and convenient method of preconditioning organs against IRI. However, the efficacy of RIPC in patients undergoing living donor kidney transplantation need to be established and mechanism of early and late RIPC, such as whether the donor should undergo remote preconditioning or the recipient, need to be investigated.

Official Title
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Effect of Lower Limb Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

Conditions
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Kidney Diseases, Kidney Failure, Chronic, Kidney Failure, Renal Insufficiency, Renal Insufficiency, Chronic, Urologic Diseases

Intervention / Treatment
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* Device: remote ischaemic preconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation Living donors Compatible ABO blood type PRA < 20% Exclusion Criteria: Re-transplant patients Those with peripheral vascular disease affecting the lower limbs
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: control<br>patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min | |
| Experimental: donor<br>Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes. | Device: remote ischaemic preconditioning<br>* Remote ischaemic preconditioning consisted of three 5-min cycles of left lower limb ischaemia, which was induced by an automated cuff-inflator placed on the left lower limb and inflated to 300 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.<br>* Other names: RIPC;|
| Experimental: recipient<br>recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes. | Device: remote ischaemic preconditioning<br>* Remote ischaemic preconditioning consisted of three 5-min cycles of left lower limb ischaemia, which was induced by an automated cuff-inflator placed on the left lower limb and inflated to 300 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.<br>* Other names: RIPC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Creatine Concentration of the Recipients | Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping | within the first 3days after the operation | 
| Urinary Output of the Recipients Postoperatively | Accumulated urinary output 1hour, 4hours and 24hours after the artery unclamping and the urinary output on the 2nd and 3rd day after the operation | within the first 3days after the operation | 
| Plasma Concentration of NGAL in the Recipients | Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping | within the first 24hours after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Rejection of Transplanted Kidney | biopsy-confirmed, clinically symptomatic | before discharge | 
| Delayed Graft Function | Delayed Graft Function according to the clinical symptoms | before discharge | 
| Length of Postoperative Hospital Stay | time from the day of operation to the day of discharge for the recipients | before discharge | 
| Total Costs During the Hospitalization | Total costs from the admission to the discharge of the recipients | from the admission to the discharge of the patients | 
| Urine Concentration of NAG Preoperatively in Recipients | Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation | before operation | 
| Urine Concentration of NAG Postoperatively in Recipients | Urine concentration of N-acetyl-D-glucosaminidase (NAG) 1hour, 4hours and 24hours after the artery unclamping in the recipients | within the first 24hours after the artery unclamping | 
| Urine Concentration of RBP Preoperatively in the Recipients | Urine concentration of retinol binding protein (RBP) before the operation in the recipients | before the operation | 
| Urine Concentration of RBP Postoperatively in the Recipients | Urine concentration of retinol binding protein (RBP) 1hour, 4hours and 24hours after the artery unclamping in the recipients | within the first 24hours after the artery unclamping | 
| Plasma Concentration of SOD in the Recipients | Plasma concentration of superoxide dismutase (SOD) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients | within 24hours after the operation | 
| Plasma Concentration of MDA in the Recipients | Plasma concentration of malondialdehyde (MDA) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients | within the first 24hours after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote ischaemic preconditioning, kidney transplantation