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The Effect of Remote Ischemic Preconditioning in Living Donor Hepatectomy

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ClinicalTrials.gov Identifier: NCT03386435
Recruitment Status : Completed
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Jun-Gol Song, Asan Medical Center

Brief Summary:
It has been demonstrated that liver ischemia/reperfusion injury (IRI) was associated with poor outcomes after liver resection. Remote ischemic preconditioning (RIPC) has been shown to have protective effects on liver IRI. However, impact of RIPC on living donor hepatectomy has not been elucidated. In this study, the investigators tried to elucidate the effects of RIPC on postoperative liver function test after living donor hepatectomy.

Condition or disease Intervention/treatment Phase
Tissue Donors Liver Transplantation Ischemia Reperfusion Injury Procedure: remote ischemic preconditioning Not Applicable

Detailed Description:

Liver ischemia/reperfusion (IR) injury (IRI) is a phenomenon in which cellular damage caused by hypoxia is accentuated following return of blood flow and restoration of oxygen delivery. This remains an important clinical problem during shock, hepatic resection, and liver transplantation.

Remote ischemic preconditioning (RIPC), involves brief periods of ischemia followed by reperfusion of one organ or tissue that subsequently affords protection to a remote organ or tissue suffering from a prolonged ischemic injury. RIPC of the limb reduces IRI to the heart, lungs, and other organs in humans and animals. Studies have investigated the protective effect of RIPC of the hind limb in reducing the adverse effects of liver IRI and underlying mechanism involved in increased hepatic blood flow, the role of heme oxygenase, modulation of the hepatic microcirculation, the role of High Mobility Group-Box1and, and others.

However, impact of RIPC on living donor hepatectomy has not been elucidated. In this study, the investigators tried to elucidate the effects of RIPC on postoperative liver function test after living donor hepatectomy.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: study group : remote ischemic preconditioning control group : none
Masking: Single (Participant)
Masking Description: single blind masking
Primary Purpose: Prevention
Official Title: The Effect of Remote Ischemic Preconditioning on the Postoperative Liver Function in Living Donor Hepatectomy: a Randomized Clinical Trial
Actual Study Start Date : August 22, 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : October 30, 2017

Arm Intervention/treatment
Active Comparator: RIPC group
received remote ischemic preconditioning
Procedure: remote ischemic preconditioning
transient brief episodes of ischemia at a remote site before a subsequent prolonged ischemia/reperfusion injury of the target organ
No Intervention: control group
no intervention



Primary Outcome Measures :
  1. postoperative liver function [ Time Frame: 7 days ]
    laboratory findings in postoperative 7 days


Secondary Outcome Measures :
  1. acute kidney injury [ Time Frame: 7 days ]
    serum creatinine levels in postoperative 7 days



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Donors who plan to have living right hepatectomy for liver transplantation.
  • age : between 20 to 60 years.

Exclusion Criteria:

  • donors who plan to donate left lobe
  • donors who cannot proceed remote ischemic preconditioning

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386435


Locations
Korea, Republic of
Asan medical center
Seoul, Songpa-gu, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Jun-Gol Song, Ph.D. Asan Medical Center

Publications:

Responsible Party: Jun-Gol Song, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03386435     History of Changes
Other Study ID Numbers: RIPC_donor
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jun-Gol Song, Asan Medical Center:
remote ischemic preconditioning
liver donors

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications