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

This study has been completed.
Sponsor:
Collaborator:
B. Braun Medical SA
Information provided by (Responsible Party):
Hua Zheng, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01289548
First received: February 2, 2011
Last updated: July 8, 2013
Last verified: September 2012
  Purpose

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


Condition Intervention
Kidney Diseases
Kidney Failure, Chronic
Kidney Failure
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Device: remote ischaemic preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Lower Limb Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Plasma Creatine Concentration of the Recipients [ Time Frame: within the first 3days after the operation ] [ Designated as safety issue: No ]
    Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping

  • Urinary Output of the Recipients Postoperatively [ Time Frame: within the first 3days after the operation ] [ Designated as safety issue: No ]
    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 [ Time Frame: within the first 24hours after the operation ] [ Designated as safety issue: No ]
    Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping


Secondary Outcome Measures:
  • Acute Rejection of Transplanted Kidney [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]
    biopsy-confirmed, clinically symptomatic

  • Delayed Graft Function [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]
    Delayed Graft Function according to the clinical symptoms

  • Length of Postoperative Hospital Stay [ Time Frame: before discharge ] [ Designated as safety issue: No ]
    time from the day of operation to the day of discharge for the recipients

  • Total Costs During the Hospitalization [ Time Frame: from the admission to the discharge of the patients ] [ Designated as safety issue: No ]
    Total costs from the admission to the discharge of the recipients

  • Urine Concentration of NAG Preoperatively in Recipients [ Time Frame: before operation ] [ Designated as safety issue: No ]
    Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation

  • Urine Concentration of NAG Postoperatively in Recipients [ Time Frame: within the first 24hours after the artery unclamping ] [ Designated as safety issue: No ]
    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 [ Time Frame: before the operation ] [ Designated as safety issue: No ]
    Urine concentration of retinol binding protein (RBP) before the operation in the recipients

  • Urine Concentration of RBP Postoperatively in the Recipients [ Time Frame: within the first 24hours after the artery unclamping ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 24hours after the operation ] [ Designated as safety issue: No ]
    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 [ Time Frame: within the first 24hours after the operation ] [ Designated as safety issue: No ]
    Plasma concentration of malondialdehyde (MDA) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients


Enrollment: 120
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min
Experimental: donor
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
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.
Other Name: RIPC
Experimental: recipient
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
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.
Other Name: RIPC

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289548

Locations
China, Hubei
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
B. Braun Medical SA
Investigators
Study Chair: Yuke Tian, M.D. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  More Information

No publications provided by Huazhong University of Science and Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hua Zheng, M.D. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01289548     History of Changes
Other Study ID Numbers: TJMZK201001
Study First Received: February 2, 2011
Results First Received: September 5, 2012
Last Updated: July 8, 2013
Health Authority: China: Ministry of Health

Keywords provided by Huazhong University of Science and Technology:
remote ischaemic preconditioning
kidney transplantation

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on July 31, 2014