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

December 24, 2013 updated by: Jong Hwan Lee, Samsung Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Samsung Seoul Hospital, Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
before surgery and at 2, 6, 12 h after declaming of renal artery
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
before surgery and at 2, 6, 12, 24, 48, 72 h after declaming of renal artery
outcome of kidney transplantation
Time Frame: at 72 h after declaming of renal artery
number of acute rejection or number of delayed graft function
at 72 h after declaming of renal artery
postoperative hospital stay
Time Frame: at postoperative day 60
length of postoperative hospital stay (days)
at postoperative day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Study Director: Jong Hwan Lee, M.D.,Ph.D., Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 23, 2011

First Submitted That Met QC Criteria

May 31, 2011

First Posted (Estimate)

June 1, 2011

Study Record Updates

Last Update Posted (Estimate)

December 25, 2013

Last Update Submitted That Met QC Criteria

December 24, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-03-047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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