The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soonchunhyang University Hospital
• Collaborators: Hanyang University; Korea University Anam Hospital; Kyunghee University; Severance Hospital; Stanford University; Wonju Severance Christian Hospital

Criteria

Inclusion Criteria:

• Age ≥ 19 and ≤ 70 years;

• Presence of liver cirrhosis

• Serum albumin level ≤ 3.5g/dl, ultrasound or CT scan confirmed ascites (≥Grade 1)

• No administration of diuretics and BCAA within the past 1 week

• Voluntary consent to take part in this trial

Exclusion Criteria:

• Child-Pugh score > 12

• Having been diagnosed as HCC within the past 5 years

• Serum creatinine > 1.5mg/dl

• Serum bilirubin > 5.0mg/dl

• Presence of such complications as SBP, or hepatic encephalopathy(West Haven grade ≥ 3)

• Patients who experienced organ failure by acute exacerbation of liver cirrhosis within the past 1 month

• Presence of serious cardiac or respiratory disease

• Contraindicated to either diuretics or BCAA

• Having commenced anti-viral treatment against hepatitis C, B within the past 1 month

• Pregnant or lactating women

• Chronic alcohol taker

• Woman patients who do not agree to the contraception from baseline to 12 month

• Unsuitable patients judged by investigator

• Patients participating in another clinical trial within 1 month