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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jong Hwan Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01363687
First received: May 23, 2011
Last updated: December 24, 2013
Last verified: December 2013
  Purpose
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.

Condition Intervention
Kidney Transplantation Ischemic Reperfusion Injury Remote Ischemic Postconditioning Device: remote ischemic postconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by Jong Hwan Lee, Samsung Medical Center:

Primary Outcome 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 Outcome 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)


Enrollment: 60
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote ischemic postconditioning group
Recipients receive remote ischemic postconditioning after declamping of renal artery during kidney transplantation
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.
No Intervention: Control group
Patients who have a deflated cuff placed on the upper limb free of arteriovenous fistula during the surgery

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.
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01363687

Locations
Korea, Republic of
Samsung Seoul Hospital, Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Director: Jong Hwan Lee, M.D.,Ph.D. Samsung Medical Center
Principal Investigator: Won Ho Kim, M.D. Samsung Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jong Hwan Lee, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01363687     History of Changes
Other Study ID Numbers: 2011-03-047
Study First Received: May 23, 2011
Last Updated: December 24, 2013

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications

ClinicalTrials.gov processed this record on June 23, 2017