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

Not Applicable

Completed

• Conditions: Kidney Transplantation; Ischemic Reperfusion Injury; Remote Ischemic Postconditioning
• Interventions: Device: remote ischemic postconditioning

• Registration Number: NCT01363687
• Lead Sponsor: Samsung Medical Center

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 Timeline

• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-05-31
• Study First Posted: 2011-06-01
• Study Start: 2011-08
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-24
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote ischemic postconditioning group	remote ischemic postconditioning	Recipients receive remote ischemic postconditioning after declamping of renal artery during kidney transplantation

Primary Outcome Measures

Name	Time	Method
renal function of recipient after living-related kidney transplantation	at 72 h after declaming of renal artery	serum creatinine concentration and urine output

Secondary Outcome Measures

Name	Time	Method
Biomarkers of acute kidney injury	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	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	at 72 h after declaming of renal artery	number of acute rejection or number of delayed graft function
postoperative hospital stay	at postoperative day 60	length of postoperative hospital stay (days)

Trial Locations

Locations (1)

Samsung Seoul Hospital, Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of