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

Phase 4

Completed

• Conditions: Living Donor Liver Transplantation
• Interventions: Drug: Ascites replacement with albumin and hartmann's solution; Drug: Ascites replacement with hartmann's solution

• Registration Number: NCT04184401
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-12-01
• Study First Posted: 2019-12-03
• Study Start: 2020-01-01
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Replacement with albumin	Ascites replacement with albumin and hartmann's solution	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
Replacement with Hartmann's solution	Ascites 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

Primary Outcome Measures

Name	Time	Method
Time to 1st flatus	within 4 weeks	Interval between SICU admission and 1st flatus
Time to 1st diet	within 4 weeks	Interval between SICU admission and 1st diet

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of