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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363687
• Other study ID #: 2011-03-047
• Status: Completed
• Phase: N/A
• First received: May 23, 2011
• Last updated: December 24, 2013
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: December 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemia
• Ischemic Reperfusion Injury
• Kidney Transplantation
• Remote Ischemic Postconditioning
• Reperfusion Injury

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Seoul Hospital, Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function of recipient after living-related kidney transplantation	serum creatinine concentration and urine output	1 day before surgery	No
Primary	renal function of recipient after living-related kidney transplantation	serum creatinine concentration and urine output	at 2 h after declaming of renal artery	No
Primary	renal function of recipient after living-related kidney transplantation	serum creatinine concentration and urine output	at 6 h after declaming of renal artery	No
Primary	renal function of recipient after living-related kidney transplantation	serum creatinine concentration and urine output	at 12 h after declaming of renal artery	No
Primary	renal function of recipient after living-related kidney transplantation	serum creatinine concentration and urine output	at 24 h after declaming of renal artery	No
Primary	renal function of recipient after living-related kidney transplantation	serum creatinine concentration and urine output	at 48 h after declaming of renal artery	No
Primary	renal function of recipient after living-related kidney transplantation	serum creatinine concentration and urine output	at 72 h after declaming of renal artery	No
Secondary	Biomarkers of acute kidney injury	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	No
Secondary	Hemodynamic parameters	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	Yes
Secondary	outcome of kidney transplantation	number of acute rejection or number of delayed graft function	at 72 h after declaming of renal artery	No
Secondary	postoperative hospital stay	length of postoperative hospital stay (days)	at postoperative day 60	No