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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Living Donor Liver Transplantation

Treatments: Drug: Ascites replacement with albumin and hartmann's solution; Drug: Ascites replacement with hartmann's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04184401

H-1902-077-1011

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups

Replacement with albumin

Experimental group

Description:

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

Treatment:

Drug: Ascites replacement with albumin and hartmann's solution

Replacement with Hartmann's solution

Active Comparator group

Description:

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

Treatment:

Drug: Ascites replacement with hartmann's solution