The Effect of Remote Ischemic Postconditioning on Liver Graft and Renal Function in Patients Undergoing Living-related Liver Transplantation

Remote Ischemic Postconditioning Clinical Trial

Official title:

The Effect of Remote Ischemic Postconditioning on Liver Graft and Renal Function in Patients Undergoing Living-related Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637038
• Other study ID #: 2012-06-010-001
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: December 24, 2013
• Start date: June 2012
• Est. completion date: February 2013

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 investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on liver graft function and postoperative renal function in subjects undergoing living-donor liver transplantation.

Description:

Ischemic reperfusion injury of liver graft and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing liver transplantation. The incidence of postoperative renal dysfunction was reported as high as 12 ~ 64% and is thought to be caused by ischemia/reperfusion injury. Ischemic pre- or postconditioning was reported to be effective for preventing ischemia/reperfusion injury during liver transplantation. Remote ischemic pre- or postconditioning was also reported to be protective for ischemia/reperfusion injury in major organs in previous animal studies. Therefore, we are trying to evaluate the clinical effect of remote ischemic postconditioning on liver graft function and postoperative renal function in subjects undergoing living-donor liver transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subjects undergoing living donor liver transplantation during the study period

• Subjects older than 20 yrs who can give written informed consent

Exclusion Criteria:

• Re-transplanted recipients

• Those with peripheral vascular diseases affecting the extremities

• Those with hepatic encephalopathy

• Those with cirrhotic cardiomyopathy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Ischemia
• Ischemia/Reperfusion Injury of Kidney
• Ischemia/Reperfusion Injury of Liver Graft
• Remote Ischemic Postconditioning
• Reperfusion Injury

Intervention

Other:
• RIPC
Those undergoing 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 unilateral upper limb 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 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	total bilirubin	total bilirubin before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery	before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery	No
Secondary	Renal Function Test profiles	Serum BUN, creatinine concentration, estimated GFR and urine output before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery	Before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery	No
Secondary	Liver Function Test Profiles	AST, ALT, albumin, before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery	before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery	No
Secondary	incidence of Surgical Outcome	incidence of acute rejection of transplanted Liver (Biopsy-confirmed or clinically symptomatic),incidence of Delayed graft function : clinically symptomatic, incidecne of Postoperative renal replacement therapy	1 week, 1 month after the end of surgery	No
Secondary	Length of hospital stay (days)	total hospital stay, ICU stay, postoperative stay	1 month, 2 month, 3 month after the end of surgery	No