Fluid Management Strategies on Blood Loss in Liver Transplantation

April 8, 2025 updated by: National Taiwan University Hospital

Effects of Different Fluid Management Strategies on Blood Loss, Inflammatory Response, and Major Organ Sequelae in Liver Transplantation

During liver transplantation, due to the complexity of the operation and abnormal coagulation function, there may be a large amount of bleeding and corresponding blood transfusion. Excessive blood transfusion will increase pulmonary complications and affect the prognosis. Infusion management to reduce bleeding is a very important issue in liver transplant surgery. Restrictive infusion management can effectively reduce the amount of bleeding in liver transplantation, but it remains unclear whether it will cause sequelae in other major organs.

The investigators plan to study different infusion goals and strategies in liver transplant surgery using a randomized group model, using the PiCCO (Pulse Contour Cardiac Output) cardiopulmonary volume monitor, and setting the stroke volume variation (SVV) as the macroscopic circulation.The purpose of this study was to divide it into restrictive and liberal groups to explore the impact on liver transplantation bleeding volume and inflammatory response as well as postoperative lung and renal function, and to collect statistics on clinical care and postoperative sequelae (pulmonary liver, renal function impairment, etc.) in order to develop the most appropriate infusion management strategy in liver transplantation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kuang-Cheng Chan, M.D.,PhD.
  • Phone Number: 262158 +886-2-23123456
  • Email: jkjchan@gmail.com

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Kuang-Cheng Chan

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

Description

Inclusion Criteria:

  • end stage liver disease
  • age between 18y/o to 75 y/o
  • expected to recieve to receive liver transplantation

Exclusion Criteria:

  • arrythmia

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Liberal group
stroke volume variation < 10%
Other: Liberal group
Fluid challage to keep stroke volume variation < 10%
Experimental: restrictive group
stroke volume variation < 18%
Other: restrictive group
Fluid challage to keep stroke volume variation < 18%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss intraoperatively
Time Frame: during the operation
blood loss intraoperatively in liver transplant
during the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung injury biomarker
Time Frame: from biginning of the operation to postoprative day 1
serum Clara Cell Protein (CC16)
from biginning of the operation to postoprative day 1
Kidney injury biomarker
Time Frame: from biginning of the operation to postoprative day 1
serum Neutrophil Gelatinase Associated Lipocalins (NGALs)
from biginning of the operation to postoprative day 1
Influammatory reponses
Time Frame: from biginning of the operation to postoprative day 1
IL-6
from biginning of the operation to postoprative day 1

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Kuang-Cheng Chan, M.D.,PhD., Department of Anesthesiology, National Taiwan University Hospital

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 (Actual)

January 15, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202308015MINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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