The Effect of Remote Ischemic Preconditioning in Living Donor Hepatectomy

NCT03386435 | Completed Results

• 1 other identifier: RIPC_donor
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Liver transplantation is the gold standard treatment for patients with end-stage liver disease. Despite its outstanding success, liver transplantation still entails certain complications including ischemia-reperfusion injury. Remote ischemic preconditioning is a novel and simple therapeutic method to lessen the harmful effects of ischemia-reperfusion injury, however, the majority of remote ischemic preconditioning studies on hepatic ischemia-reperfusion injury have been animal studies. Therefore, our aim was to assess the effects of remote ischemic preconditioning on postoperative liver function in living donor hepatectomy.

Conditions

Tissue Donors; Liver Transplantation; Ischemia Reperfusion Injury

Keywords

remote ischemic preconditioning; liver donors

Outcome Measures

Primary Outcomes (2)

• Postopera The Maximal Aspartate Aminotransferase Level Within 7 Postoperative Days

  The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal aspartate aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy.

  within 7 days after operation

• The Maximal Alanine Aminotransferase Level Within 7 Postoperative Days

  The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal alanine aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy

  within 7 days after operation

Secondary Outcomes (2)

• Number of Participants With Delayed Recovery of Liver Function

  postoperative 7 days

• Postoperative Liver Regeneration

  1 month

Study Arms (2)

RIPC

EXPERIMENTAL

intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started.

Procedure: remote ischemic preconditioning

Control

NO INTERVENTION

In the control group, the same maneuver was applied but without cuff inflation.

Interventions

remote ischemic preconditioning PROCEDURE

Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated

Also known as: RIPC

RIPC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Donors who plan to have living right hepatectomy for liver transplantation.
• age : between 18 to 60 years.

You may not qualify if:

• donors who plan to donate left lobe
• donors who plan to have laparoscopic right hepatectomy
• donors who cannot proceed remote ischemic preconditioning

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan medical center

Seoul, Songpa-gu, 05505, South Korea

Location

Related Publications (24)

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MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jun-Gol Song, MD, PhD
• Organization: Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

jungol.song@amc.seoul.kr

+82-2-3010-3869

Study Officials

• Jun-Gol Song, Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: study group : remote ischemic preconditioning control group : none

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 29, 2017
• Study Start: August 22, 2016
• Primary Completion: August 31, 2017
• Study Completion: October 30, 2017
• Last Updated: August 19, 2019
• Results First Posted: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)