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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Huazhong University of Science and Technology.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
B. Braun Medical SA
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01289548
First received: February 2, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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, Outcomes Assessor)
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • renal function of recipients after living-related kidney transplantation [ Time Frame: 72 postoperative hours ] [ Designated as safety issue: No ]
    Serum creatinine concentration and Urine output before surgery and at 1, 4, 24, 48, and 72 h after unclamping


Secondary Outcome Measures:
  • hemodynamic parameters [ Time Frame: during operation ] [ Designated as safety issue: Yes ]
    blood pressure (BP), heart rate (HR), central venous pressure (CVP) and SpO2

  • 0peration time [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • warm ischemic time [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • cold ischemic time [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • 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 ]
    clinically symptomatic

  • Length of postoperative hospital stay [ Time Frame: before discharge ] [ Designated as safety issue: No ]
  • Ischemia reperfusion injury of recipients after living-related kidney transplantation [ Time Frame: 24 postoperative hours ] [ Designated as safety issue: No ]
    urine N-acetyl-β-D-glucosaminidase and Retinol binding protein before surgery and at 1, 4 and 24h after unclamping; Serum Superoxide dismutase and Malondialdehyde before surgery and at 1, 4 and 24h after unclamping


Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
patients 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
 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.
Experimental: recipient
recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started
 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.

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

Contacts
Contact: Hua Zheng 00862783663173 huaz1980@hotmail.com

Locations
China, Hubei
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Hua Zheng     00862783663173     huaz1980@hotmail.com    
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: Yuke Tian, Professor, Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology
ClinicalTrials.gov Identifier: NCT01289548     History of Changes
Other Study ID Numbers: TJMZK201001
Study First Received: February 2, 2011
Last Updated: February 2, 2011
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 May 19, 2013