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Completed

NCT Number: NCT04184401

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

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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Key information

Conditions

Living Donor Liver Transplantation Ascites Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ascites replacement with albumin and hartmann's solution

Drug

Combined strategy for ascites replacement

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

Other names: Experimental

Ascites replacement with hartmann's solution

Drug

Hartmann's solution only strategy for ascites replacement

  • 70% of ascites: replacement with Hartmann's solution

Other names: No intervention

Primary outcomes

  1. Time to 1st flatus

    Time frame: within 4 weeks

    Interval between SICU admission and 1st flatus

  2. Time to 1st diet

    Time frame: within 4 weeks

    Interval between SICU admission and 1st diet

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • GC Pharma

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2019
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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