The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation

Overview

The purpose of this study is to investigate whether upper limb ischemic postconditioning can improve renal function and decrease ischemic-reperfusion injury in patients undergoing living donor kidney transplantation.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: May 2012

Detailed Description

Ischemic reperfusion injury after kidney transplantation is a common clinical problem associated with a high morbidity and mortality. To reduce the adverse effect of ischemic reperfusion injury after organ transplantation, various strategies including ischemic preconditioning or postconditioning. Remote ischemic postconditioning is one of such strategies where brief ischemic reperfusion injury of one organ protects other organs from sustained ischemic reperfusion injury. Remote ischemic postconditioning of the limb with a tourniquet is a safe and convenient method of postconditioning organs against ischemic reperfusion injury. However, the efficacy of remote ischemic postconditioning in patients undergoing living donor kidney transplantation needs to be established. Therefore, we investigate the efficacy of remote ischemic postconditioning of the upper limb with a tourniquet in recipients of kidney transplantation by measuring the markers of acute kidney injury.

Interventions

  • Device: remote ischemic postconditioning
    • Remote ischemic postconditioning consists of three 5-min cycles of upper limb ischemia, which was induced by an automated cuff-inflator placed on the upper limb free of arteriovenous fistula and inflated to 250 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.

Arms, Groups and Cohorts

  • Experimental: Remote ischemic postconditioning group
    • Recipients receive remote ischemic postconditioning after declamping of renal artery during kidney transplantation
  • No Intervention: Control group
    • Patients who have a deflated cuff placed on the upper limb free of arteriovenous fistula during the surgery

Clinical Trial Outcome Measures

Primary Measures

  • renal function of recipient after living-related kidney transplantation
    • Time Frame: 1 day before surgery
    • serum creatinine concentration and urine output
  • renal function of recipient after living-related kidney transplantation
    • Time Frame: at 2 h after declaming of renal artery
    • serum creatinine concentration and urine output
  • renal function of recipient after living-related kidney transplantation
    • Time Frame: at 6 h after declaming of renal artery
    • serum creatinine concentration and urine output
  • renal function of recipient after living-related kidney transplantation
    • Time Frame: at 12 h after declaming of renal artery
    • serum creatinine concentration and urine output
  • renal function of recipient after living-related kidney transplantation
    • Time Frame: at 24 h after declaming of renal artery
    • serum creatinine concentration and urine output
  • renal function of recipient after living-related kidney transplantation
    • Time Frame: at 48 h after declaming of renal artery
    • serum creatinine concentration and urine output
  • renal function of recipient after living-related kidney transplantation
    • Time Frame: at 72 h after declaming of renal artery
    • serum creatinine concentration and urine output

Secondary Measures

  • Biomarkers of acute kidney injury
    • Time Frame: before surgery and at 2, 6, 12 h after declaming of renal artery
    • biomarkers of acute kidney injury: Plasma cystatin-C, Urine IL-18, Urine Neutrophil gelatinase-associated lipocalin (NGAL)
  • Hemodynamic parameters
    • Time Frame: before surgery and at 2, 6, 12, 24, 48, 72 h after declaming of renal artery
    • arterial blood pressure, heart rate, central venous pressure, pulse oximetry
  • outcome of kidney transplantation
    • Time Frame: at 72 h after declaming of renal artery
    • number of acute rejection or number of delayed graft function
  • postoperative hospital stay
    • Time Frame: at postoperative day 60
    • length of postoperative hospital stay (days)

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects undergoing elective living donor kidney transplantation – subjects older than 20 yrs who can give written informed consent Exclusion Criteria:

  • re-transplant recipients – those with peripheral vascular disease affecting the upper limbs free of arteriovenous fistula

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jong Hwan Lee, Assistant Professor – Samsung Medical Center
  • Overall Official(s)
    • Jong Hwan Lee, M.D.,Ph.D., Study Director, Samsung Medical Center
    • Won Ho Kim, M.D., Principal Investigator, Samsung Medical Center

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