The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- renal function of recipient after living-related kidney transplantation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Remote ischemic postconditioning group
Recipients receive remote ischemic postconditioning after declamping of renal artery during kidney transplantation
Intervention: remote ischemic postconditioning (Device)
Control group
Patients who have a deflated cuff placed on the upper limb free of arteriovenous fistula during the surgery
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Biomarkers of acute kidney injury(before surgery and at 2, 6, 12 h after declaming of renal artery)
- Hemodynamic parameters(before surgery and at 2, 6, 12, 24, 48, 72 h after declaming of renal artery)
- outcome of kidney transplantation(at 72 h after declaming of renal artery)
- postoperative hospital stay(at postoperative day 60)
Investigators
Jong Hwan Lee
Assistant Professor
Samsung Medical Center