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

Living Donor Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184401
• Other study ID #: H-1902-077-1011
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Living Donor Liver Transplantation

Intervention

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
• Ascites replacement with hartmann's solution
Hartmann's solution only strategy for ascites replacement - 70% of ascites: replacement with Hartmann's solution

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	GC Pharma

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to 1st flatus	Interval between SICU admission and 1st flatus	within 4 weeks
Primary	Time to 1st diet	Interval between SICU admission and 1st diet	within 4 weeks