Effect of Ascites Replacement Strategy on Time to 1st Flatus After LDLT

July 10, 2023 updated by: Ho Geol Ryu, Seoul National University Hospital

Effect of Albumin Administration Strategy for Ascites Replacement on Time to 1st Flatus After Liver Transplantation

The aim of this study is to evaluate difference in the rate of recovery of intestinal motility according to different ascites replacement strategy after living donor liver transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (19 years or older)
  • Elective living donor liver transplantation

Exclusion Criteria:

  • Previous abdominal surgery
  • Renal failure requiring renal replacement therapy

  • Contraindications for 5% albumin use

    1. Condition with potential risk caused by increased circulating plasma (heart failure, renal failure combined with oliguria, pulmonary edema)
    2. Hemolytic anemia

  • Contraindications for Hartmann solution

    1. Progressive lactic acidosis
    2. Hypervolemia
    3. Hypernatremia

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Replacement with albumin
  1. Check drain amount every 4 hour after SICU admission

  2. Replacement of 70% of drainage from previous 4 hours over next 4 hours

    • 30% of the drainage with 5% albumin
    • 40% of drainage with Hartmann's solution
    • If, serum K + level> 5mEq/L, replace with 0.9% saline instead of Hartmann solution
    • If, serum albumin level is below 2.6 g/dL, inject 100mL of 20% albumin
Drug: Ascites replacement with albumin and hartmann's solution

Combined strategy for ascites replacement

  • 30% of ascites: replacement with 5% albumin
  • 40% of ascites: replacement with Hartmann's solution
Other Names:
  • Experimental
Active Comparator: Replacement with Hartmann's solution
  1. Check drain amount every 4 hour after SICU admission

  2. Replacement of 70% of drainage from previous 4 hours with Hartmann's solution over next 4 hours

    • If, serum K + level> 5mEq/L, replace with 0.9% saline instead of Hartmann solution
    • If, serum albumin level is below 2.6 g/dL, inject 100mL of 20% albumin
Drug: Ascites replacement with hartmann's solution

Hartmann's solution only strategy for ascites replacement

- 70% of ascites: replacement with Hartmann's solution

Other Names:
  • No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to 1st flatus
Time Frame: within 4 weeks
Interval between SICU admission and 1st flatus
within 4 weeks
Time to 1st diet
Time Frame: within 4 weeks
Interval between SICU admission and 1st diet
within 4 weeks

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

GC Pharma

Investigators

  • Principal Investigator: Ho Geol Ryu, MD, PhD, Seoul National 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 1, 2020

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

December 1, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1902-077-1011

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

product manufactured in and exported from the U.S.

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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