Clinical trial NCT01363687: 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
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Ischemic Reperfusion Injury
Remote Ischemic Postconditioning
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: renal function of recipient after living-related kidney transplantation
timeFrame: 1 day before surgery
measure: renal function of recipient after living-related kidney transplantation
timeFrame: at 2 h after declaming of renal artery
measure: renal function of recipient after living-related kidney transplantation
timeFrame: at 6 h after declaming of renal artery
measure: renal function of recipient after living-related kidney transplantation
timeFrame: at 12 h after declaming of renal artery
measure: renal function of recipient after living-related kidney transplantation
timeFrame: at 24 h after declaming of renal artery
measure: renal function of recipient after living-related kidney transplantation
timeFrame: at 48 h after declaming of renal artery
measure: renal function of recipient after living-related kidney transplantation
timeFrame: at 72 h after declaming of renal artery
Secondary outcomes:
measure: Biomarkers of acute kidney injury
timeFrame: before surgery and at 2, 6, 12 h after declaming of renal artery
measure: Hemodynamic parameters
timeFrame: before surgery and at 2, 6, 12, 24, 48, 72 h after declaming of renal artery
measure: outcome of kidney transplantation
timeFrame: at 72 h after declaming of renal artery
measure: postoperative hospital stay
timeFrame: at postoperative day 60
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Seoul Hospital, Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jong Hwan Lee, M.D.,Ph.D.
role: STUDY_DIRECTOR
affiliation: Samsung Medical Center
name: Won Ho Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.