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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Living Donor Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Ascites replacement with albumin and hartmann's solution

Intervention Type DRUG

Combined strategy for ascites replacement

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

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

Group Type ACTIVE_COMPARATOR

Ascites replacement with hartmann's solution

Intervention Type DRUG

Hartmann's solution only strategy for ascites replacement

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

Interventions

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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

Intervention Type DRUG

Ascites replacement with hartmann's solution

Hartmann's solution only strategy for ascites replacement

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

Intervention Type DRUG

Other Intervention Names

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Experimental No intervention

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No