Clinical trial NCT01289548: Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
Official title: Effect of Lower Limb Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases
Kidney Failure, Chronic
Kidney Failure
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Keywords: remote ischaemic preconditioning
kidney transplantation
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: B. Braun Medical SA
First posted: 2011-02-03
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma Creatine Concentration of the Recipients
timeFrame: within the first 3days after the operation
measure: Urinary Output of the Recipients Postoperatively
timeFrame: within the first 3days after the operation
measure: Plasma Concentration of NGAL in the Recipients
timeFrame: within the first 24hours after the operation
Secondary outcomes:
measure: Acute Rejection of Transplanted Kidney
timeFrame: before discharge
measure: Delayed Graft Function
timeFrame: before discharge
measure: Length of Postoperative Hospital Stay
timeFrame: before discharge
measure: Total Costs During the Hospitalization
timeFrame: from the admission to the discharge of the patients
measure: Urine Concentration of NAG Preoperatively in Recipients
timeFrame: before operation
measure: Urine Concentration of NAG Postoperatively in Recipients
timeFrame: within the first 24hours after the artery unclamping
measure: Urine Concentration of RBP Preoperatively in the Recipients
timeFrame: before the operation
measure: Urine Concentration of RBP Postoperatively in the Recipients
timeFrame: within the first 24hours after the artery unclamping
measure: Plasma Concentration of SOD in the Recipients
timeFrame: within 24hours after the operation
measure: Plasma Concentration of MDA in the Recipients
timeFrame: within the first 24hours after the operation
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Yuke Tian, M.D.
role: STUDY_CHAIR
References:
citation: Chen Y, Zheng H, Wang X, Zhou Z, Luo A, Tian Y. Remote ischemic preconditioning fails to improve early renal function of patients undergoing living-donor renal transplantation: a randomized controlled trial. Transplantation. 2013 Jan 27;95(2):e4-6. doi: 10.1097/TP.0b013e3182782f3a. No abstract available.