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

Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289548
• Other study ID #: TJMZK201001
• Status: Completed
• Phase: N/A
• First received: February 2, 2011
• Last updated: July 8, 2013
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Device:
• remote ischaemic preconditioning
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.

Locations

Country	Name	City	State
China	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	B. Braun Medical SA

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Acute Rejection of Transplanted Kidney	biopsy-confirmed, clinically symptomatic	before discharge	Yes
Secondary	Delayed Graft Function	Delayed Graft Function according to the clinical symptoms	before discharge	Yes
Secondary	Length of Postoperative Hospital Stay	time from the day of operation to the day of discharge for the recipients	before discharge	No
Secondary	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	No
Secondary	Urine Concentration of NAG Preoperatively in Recipients	Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation	before operation	No
Secondary	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	No
Secondary	Urine Concentration of RBP Preoperatively in the Recipients	Urine concentration of retinol binding protein (RBP) before the operation in the recipients	before the operation	No
Secondary	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	No
Secondary	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	No
Secondary	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	No