Fluid Management Strategies on Blood Loss in Liver Transplantation

NCT06215404 | Recruiting

• 1 other identifier: 202308015MINC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplant

Keywords

fluid management; blood loss

Outcome Measures

Primary Outcomes (1)

• blood loss intraoperatively

  blood loss intraoperatively in liver transplant

  during the operation

Secondary Outcomes (3)

• Lung injury biomarker

  from biginning of the operation to postoprative day 1

• Kidney injury biomarker

  from biginning of the operation to postoprative day 1

• Influammatory reponses

  from biginning of the operation to postoprative day 1

Study Arms (2)

Liberal group

ACTIVE COMPARATOR

stroke volume variation \< 10%

Other: Liberal group

restrictive group

EXPERIMENTAL

stroke volume variation \< 18%

Other: restrictive group

Interventions

Liberal group OTHER

Fluid challage to keep stroke volume variation \< 10%

Liberal group

restrictive group OTHER

Fluid challage to keep stroke volume variation \< 18%

restrictive group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• arrythmia

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kuang-Cheng Chan, M.D.,PhD.

  Department of Anesthesiology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuang-Cheng Chan, M.D.,PhD.

CONTACT

+886-2-23123456; jkjchan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: January 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)