Back to resultsThe Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation
Primary Purpose
Kidney Transplantation, Ischemic Reperfusion Injury, Remote Ischemic Postconditioning
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
remote ischemic postconditioning
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Transplantation
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
Sites / Locations
- Samsung Seoul Hospital, Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Remote ischemic postconditioning group
Control group
Arm Description
Recipients receive remote ischemic postconditioning after declamping of renal artery during kidney transplantation
Patients who have a deflated cuff placed on the upper limb free of arteriovenous fistula during the surgery
Outcomes
Primary Outcome Measures
renal function of recipient after living-related kidney transplantation
serum creatinine concentration and urine output
renal function of recipient after living-related kidney transplantation
serum creatinine concentration and urine output
renal function of recipient after living-related kidney transplantation
serum creatinine concentration and urine output
renal function of recipient after living-related kidney transplantation
serum creatinine concentration and urine output
renal function of recipient after living-related kidney transplantation
serum creatinine concentration and urine output
renal function of recipient after living-related kidney transplantation
serum creatinine concentration and urine output
renal function of recipient after living-related kidney transplantation
serum creatinine concentration and urine output
Secondary Outcome Measures
Biomarkers of acute kidney injury
biomarkers of acute kidney injury: Plasma cystatin-C, Urine IL-18, Urine Neutrophil gelatinase-associated lipocalin (NGAL)
Hemodynamic parameters
arterial blood pressure, heart rate, central venous pressure, pulse oximetry
outcome of kidney transplantation
number of acute rejection or number of delayed graft function
postoperative hospital stay
length of postoperative hospital stay (days)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01363687
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Ischemic Reperfusion Injury, Remote Ischemic Postconditioning
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote ischemic postconditioning group
Arm Type
Experimental
Arm Description
Recipients receive remote ischemic postconditioning after declamping of renal artery during kidney transplantation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients who have a deflated cuff placed on the upper limb free of arteriovenous fistula during the surgery
Intervention Type
Device
Intervention Name(s)
remote ischemic postconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
renal function of recipient after living-related kidney transplantation
Description
serum creatinine concentration and urine output
Time Frame
1 day before surgery
Title
renal function of recipient after living-related kidney transplantation
Description
serum creatinine concentration and urine output
Time Frame
at 2 h after declaming of renal artery
Title
renal function of recipient after living-related kidney transplantation
Description
serum creatinine concentration and urine output
Time Frame
at 6 h after declaming of renal artery
Title
renal function of recipient after living-related kidney transplantation
Description
serum creatinine concentration and urine output
Time Frame
at 12 h after declaming of renal artery
Title
renal function of recipient after living-related kidney transplantation
Description
serum creatinine concentration and urine output
Time Frame
at 24 h after declaming of renal artery
Title
renal function of recipient after living-related kidney transplantation
Description
serum creatinine concentration and urine output
Time Frame
at 48 h after declaming of renal artery
Title
renal function of recipient after living-related kidney transplantation
Description
serum creatinine concentration and urine output
Time Frame
at 72 h after declaming of renal artery
Secondary Outcome Measure Information:
Title
Biomarkers of acute kidney injury
Description
biomarkers of acute kidney injury: Plasma cystatin-C, Urine IL-18, Urine Neutrophil gelatinase-associated lipocalin (NGAL)
Time Frame
before surgery and at 2, 6, 12 h after declaming of renal artery
Title
Hemodynamic parameters
Description
arterial blood pressure, heart rate, central venous pressure, pulse oximetry
Time Frame
before surgery and at 2, 6, 12, 24, 48, 72 h after declaming of renal artery
Title
outcome of kidney transplantation
Description
number of acute rejection or number of delayed graft function
Time Frame
at 72 h after declaming of renal artery
Title
postoperative hospital stay
Description
length of postoperative hospital stay (days)
Time Frame
at postoperative day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Hwan Lee, M.D.,Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Won Ho Kim, M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Seoul Hospital, Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24770616
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation
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