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

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ClinicalTrials.gov Identifier: NCT01289548
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : September 10, 2013
Last Update Posted : September 10, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Kidney Diseases Kidney Failure, Chronic Kidney Failure Renal Insufficiency Renal Insufficiency, Chronic Urologic Diseases Device: remote ischaemic preconditioning

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Lower Limb Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
Study Start Date : May 2010
Primary Completion Date : November 2011
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Plasma Creatine Concentration of the Recipients [ Time Frame: within the first 3days after the operation ]
    Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping

  2. Urinary Output of the Recipients Postoperatively [ Time Frame: 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

  3. Plasma Concentration of NGAL in the Recipients [ Time Frame: 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 :
  1. Acute Rejection of Transplanted Kidney [ Time Frame: before discharge ]
    biopsy-confirmed, clinically symptomatic

  2. Delayed Graft Function [ Time Frame: before discharge ]
    Delayed Graft Function according to the clinical symptoms

  3. Length of Postoperative Hospital Stay [ Time Frame: before discharge ]
    time from the day of operation to the day of discharge for the recipients

  4. Total Costs During the Hospitalization [ Time Frame: from the admission to the discharge of the patients ]
    Total costs from the admission to the discharge of the recipients

  5. Urine Concentration of NAG Preoperatively in Recipients [ Time Frame: before operation ]
    Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation

  6. Urine Concentration of NAG Postoperatively in Recipients [ Time Frame: 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

  7. Urine Concentration of RBP Preoperatively in the Recipients [ Time Frame: before the operation ]
    Urine concentration of retinol binding protein (RBP) before the operation in the recipients

  8. Urine Concentration of RBP Postoperatively in the Recipients [ Time Frame: 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

  9. Plasma Concentration of SOD in the Recipients [ Time Frame: 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

  10. Plasma Concentration of MDA in the Recipients [ Time Frame: 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


Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 3, 2011    Key Record Dates
Results First Posted: September 10, 2013
Last Update Posted: September 10, 2013
Last Verified: September 2012

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

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