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

• ClinicalTrials.gov Identifier: NCT01363687
• Recruitment Status: Completed
• First Posted: June 1, 2011
• Last Update Posted: December 25, 2013
• Sponsor: Samsung Medical Center
• Information provided by (Responsible Party): Jong Hwan Lee, Samsung Medical Center

Tracking Information

• First Submitted Date: May 23, 2011
• First Posted Date: June 1, 2011
• Last Update Posted Date: December 25, 2013
• Study Start Date: August 2011
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Kidney Transplantation
• Ischemic Reperfusion Injury
• Remote Ischemic Postconditioning

Intervention

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 31, 2011): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2012
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01363687
• Other Study ID Numbers: 2011-03-047
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jong Hwan Lee, Samsung Medical Center
• Original Responsible Party: Samsung Seoul Hospital, Samsung Medical Center
• Current Study Sponsor: Samsung Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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