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

Not Applicable

Completed

• Conditions: Kidney Diseases; Kidney Failure, Chronic; Kidney Failure; Renal Insufficiency; Renal Insufficiency, Chronic; Urologic Diseases
• Interventions: Device: remote ischaemic preconditioning

• Registration Number: NCT01289548
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• Primary Completion: 2011-11
• Study Completion: 2012-01
• Status Verified: 2012-09
• Results First Submitted: 2012-09-05
• Results First Submitted QC: 2013-07-08
• Last Update Submitted: 2013-07-08
• Results First Posted: 2013-09-10
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
donor	remote ischaemic preconditioning	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.
recipient	remote ischaemic preconditioning	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China