Perioperative Factors and Living Donor Liver Transplantation

March 14, 2024 updated by: Min Suk Chae

The Study on Perioperative Factors Affecting Postoperative Outcomes in Patients Who Underwent Adult Liver Transplantation

Liver transplant surgery is one of the treatments provided to patients suffering from end-stage liver disease, and has a successful treatment prognosis. However, it is clear that patient management before, during, and after surgery is a difficult task for medical staff due to the complex clinical and pathological problems of end-stage liver disease. Moreover, the complex surgical technique of the liver transplant surgery itself and the severe hemodynamic fluctuations and multi-organ dysfunction that patients experience during the surgery have been shown to have a tremendous impact on the patient's prognosis after surgery.

A study on which clinical, laboratory, and hemodynamic factors experienced by patients during the perioperative period, including before, during, and after surgery, affect the survival rate of patients and transplanted organs. will definitely be helpful in the treatment of patients suffering from end-stage liver disease.

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

533

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Data from adult patients undergoing elective living donor liver transplantation at Seoul St. Mary's Hospital were retrospectively collected with the electronic medical record system.

Description

Inclusion Criteria:

  • adults
  • elective surgery
  • American Society of Anesthesiologists (ASA) physical status classification system I, II, III

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status classification system IV, V

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
no-remote ischemic preconditioning group
patients who did not receive remote ischemic preconditioning
paired remote ischemic preconditioning group
patients who receive remote ischemic preconditioning
After induction of anesthesia, the paired RIPC group took the RIPC intervention on the upper arm in the lateral position. The RIPC intervention was applied using a manual cuff inflator, which consisted of three cycles of 5-min inflation of the blood pressure cuff (to 250 mmHg, or to 50 mmHg higher than the preoperative SBP), followed by 5-min deflation of the cuff. In the no-RIPC group, a blood pressure cuff was also applied on the upper arm but was not inflated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postreperfusion syndrome
Time Frame: during surgery
mean blood pressure decreases by 30% based on the value on preoperative day
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • KC21RISI0576

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used and/or analyzed during this study are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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