NCT04184401

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

November 12, 2019

Last Update Submit

July 10, 2023

Conditions

Living Donor Liver Transplantation

Keywords

AscitesAlbuminHartmann's solutionPostoperative ileus

Outcome Measures

Primary Outcomes (2)

  • Time to 1st flatus

    Interval between SICU admission and 1st flatus

    within 4 weeks

  • Time to 1st diet

    Interval between SICU admission and 1st diet

    within 4 weeks

Study Arms (2)

Replacement with albumin

EXPERIMENTAL

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

Replacement with Hartmann's solution

ACTIVE COMPARATOR

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

Interventions

Ascites replacement with albumin and hartmann's solutionDRUG

Combined strategy for ascites replacement * 30% of ascites: replacement with 5% albumin * 40% of ascites: replacement with Hartmann's solution

Also known as: Experimental
Replacement with albumin
Ascites replacement with hartmann's solutionDRUG

Hartmann's solution only strategy for ascites replacement \- 70% of ascites: replacement with Hartmann's solution

Also known as: No intervention
Replacement with Hartmann's solution

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous abdominal surgery
  • Renal failure requiring renal replacement therapy
  • Contraindications for 5% albumin use
  • Condition with potential risk caused by increased circulating plasma (heart failure, renal failure combined with oliguria, pulmonary edema)
  • Hemolytic anemia
  • Contraindications for Hartmann solution
  • Progressive lactic acidosis
  • Hypervolemia
  • Hypernatremia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Ascites

Interventions

AlbuminsRinger's Lactate

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ho Geol Ryu, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 12, 2019

First Posted

December 3, 2019

Study Start

January 1, 2020

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)