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NCT Number: NCT01637038

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

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.

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Key information

Conditions

Ischemia/Reperfusion Injury of Liver Graft Cardiovascular Diseases Ischemia Ischemia/Reperfusion Injury of Kidney Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Remote Ischemic Postconditioning Reperfusion Injury Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIPC

Other

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.

Other names: remote ischemic postconditioning

Primary outcomes

  1. total bilirubin

    Time frame: before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery

    total bilirubin before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery

Secondary outcomes

  1. Renal Function Test profiles

    Time frame: Before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery

    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

  2. Liver Function Test Profiles

    Time frame: before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery

    AST, ALT, albumin, before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery

  3. incidence of Surgical Outcome

    Time frame: 1 week, 1 month after the end of surgery

    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

  4. Length of hospital stay (days)

    Time frame: 1 month, 2 month, 3 month after the end of surgery

    total hospital stay, ICU stay, postoperative stay

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 10, 2012
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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