search
Back to results

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

Primary Purpose

Living Donor Liver Transplantation

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ascites replacement with albumin and hartmann's solution
Ascites replacement with hartmann's solution
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Living Donor Liver Transplantation focused on measuring Ascites, Albumin, Hartmann's solution, Postoperative ileus

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Replacement with albumin

Replacement with Hartmann's solution

Arm Description

Check drain amount every 4 hour after SICU admission 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

Check drain amount every 4 hour after SICU admission 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

Outcomes

Primary Outcome Measures

Time to 1st flatus
Interval between SICU admission and 1st flatus
Time to 1st diet
Interval between SICU admission and 1st diet

Secondary Outcome Measures

Full Information

First Posted
November 12, 2019
Last Updated
July 10, 2023
Sponsor
Seoul National University Hospital
Collaborators
GC Pharma
search

1. Study Identification

Unique Protocol Identification Number
NCT04184401
Brief Title
Effect of Ascites Replacement Strategy on Time to 1st Flatus After LDLT
Official Title
Effect of Albumin Administration Strategy for Ascites Replacement on Time to 1st Flatus After Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
GC Pharma

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Living Donor Liver Transplantation
Keywords
Ascites, Albumin, Hartmann's solution, Postoperative ileus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Replacement with albumin
Arm Type
Experimental
Arm Description
Check drain amount every 4 hour after SICU admission 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
Arm Title
Replacement with Hartmann's solution
Arm Type
Active Comparator
Arm Description
Check drain amount every 4 hour after SICU admission 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
Intervention Type
Drug
Intervention Name(s)
Ascites replacement with albumin and hartmann's solution
Other Intervention Name(s)
Experimental
Intervention Description
Combined strategy for ascites replacement 30% of ascites: replacement with 5% albumin 40% of ascites: replacement with Hartmann's solution
Intervention Type
Drug
Intervention Name(s)
Ascites replacement with hartmann's solution
Other Intervention Name(s)
No intervention
Intervention Description
Hartmann's solution only strategy for ascites replacement - 70% of ascites: replacement with Hartmann's solution
Primary Outcome Measure Information:
Title
Time to 1st flatus
Description
Interval between SICU admission and 1st flatus
Time Frame
within 4 weeks
Title
Time to 1st diet
Description
Interval between SICU admission and 1st diet
Time Frame
within 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Geol Ryu, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs