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

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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

Tracking Information
First Submitted Date  ICMJE May 23, 2011
First Posted Date  ICMJE June 1, 2011
Last Update Posted Date December 25, 2013
Study Start Date  ICMJE August 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
  • Biomarkers of acute kidney injury [ Time Frame: before surgery and at 2, 6, 12, 24, 48, 72 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation
Official Title  ICMJE The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Kidney Transplantation
  • Ischemic Reperfusion Injury
  • Remote Ischemic Postconditioning
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Remote ischemic postconditioning group
    Recipients receive remote ischemic postconditioning after declamping of renal artery during kidney transplantation
    Intervention: Device: remote ischemic postconditioning
  • No Intervention: Control group
    Patients who have a deflated cuff placed on the upper limb free of arteriovenous fistula during the surgery
Publications * Kim WH, Lee JH, Kim GS, Sim HY, Kim SJ. The effect of remote ischemic postconditioning on graft function in patients undergoing living donor kidney transplantation. Transplantation. 2014 Sep 15;98(5):529-36. doi: 10.1097/TP.0000000000000098.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01363687
Other Study ID Numbers  ICMJE 2011-03-047
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jong Hwan Lee, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jong Hwan Lee, M.D.,Ph.D. Samsung Medical Center
Principal Investigator: Won Ho Kim, M.D. Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP