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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363687
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Jong Hwan Lee, Samsung Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Transplantation Ischemic Reperfusion Injury Remote Ischemic Postconditioning Device: remote ischemic postconditioning Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation
Study Start Date : August 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. renal function of recipient after living-related kidney transplantation [ Time Frame: 1 day before surgery ]
    serum creatinine concentration and urine output

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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 :
  1. 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)

  2. 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

  3. outcome of kidney transplantation [ Time Frame: at 72 h after declaming of renal artery ]
    number of acute rejection or number of delayed graft function

  4. postoperative hospital stay [ Time Frame: at postoperative day 60 ]
    length of postoperative hospital stay (days)



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
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

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): NCT01363687


Locations
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Korea, Republic of
Samsung Seoul Hospital, Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Study Director: Jong Hwan Lee, M.D.,Ph.D. Samsung Medical Center
Principal Investigator: Won Ho Kim, M.D. Samsung Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jong Hwan Lee, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01363687    
Other Study ID Numbers: 2011-03-047
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: December 25, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Reperfusion Injury
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications