Role of Branched-chain Amino Acids Infusion as Adjunct Therapy Post Liver Surgery for Patients in Intensive Care Unit

NCT ID: NCT03448848

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2020-09-10

Brief Summary

The purpose of this study is to evaluate the impact of intravenous BCAAs infusion as adjunct therapy post liver surgery in intensive care unit (ICU).

Detailed Description

Patients will be enrolled in the study&randomly assigned in a 1:1 manner to receive either intravenous (IV) BCAAs in a dose of 0.5-1gm/Kg/day for at least 48hours up to maximum 5 days immediately post-operative or placebo (sterile normal saline in a volume equal to the study drug).

All demographic data will be obtained including the patients' age, sex, weight,associated co-morbidities (diabetes mellitus & hypertension), the presence of chronic liver disease (CLD), Child-Pugh score, Sequential Organ Failure Assessment (SOFA), the type of liver surgery, & nutritional status according to nutritional risk screening 2002 (NRS 2002); well-nourished if NRS 2002 < 3 while malnourished if NRS 2002 ≥ 3 prior BCAAs infusion.

Vital signs including the heart rate, mean arterial pressure (MAP), central venous pressure (CVP), arterial oxygen saturation (SaO2), insulin requirements, urine volume & fluid balance will be recorded on admission (day 0), then will be followed up and recorded at regular intervals during treatment on 1, 3, 5 &7days.

Laboratory investigations including the complete blood profile (white blood cells, band%, lymphocytes), prothrombin time (PT), liver enzymes; Aspartate aminotransferase (AST), Alanine aminotransferase (ALT),serum bilirubin, serum albumin, C-reactive protein (CRP)& kidney functions will be recorded at randomization as a baseline (day 0)& will be assessed on day 0,1, 3, 5 & 7 of the study. Thirty-day survival & infectious morbidity will be followed by phone calls to the patient or one of his/her first-degree relatives.

Conditions

Liver Function Post BCAA Infusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

study

Group Type: EXPERIMENTAL

BCAA preparation Intravenous infusion

Intervention Type: DRUG

BCAA IVi in a dose 0.5-1 gm/Kg/day for 2-5 days post liver surgery versus sterile normal saline in a volume equal to the study drug

control

Group Type: PLACEBO_COMPARATOR

sterile normal saline

Intervention Type: DRUG

sterile normal saline in a volume equal to the study drug

Interventions

BCAA preparation Intravenous infusion

BCAA IVi in a dose 0.5-1 gm/Kg/day for 2-5 days post liver surgery versus sterile normal saline in a volume equal to the study drug

Intervention Type: DRUG

sterile normal saline

sterile normal saline in a volume equal to the study drug

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The subjects are adults aged between 18& 75years who are admitted to the ICU of National Hepatology & Tropical Medicine Research Institute (NHTMRI) post liver surgery e.g. hepatocellular carcinoma, liver hemangioma, hydatid resection, segmentectomy, partial hepatectomy as in donor for living donated liver transplant.

Exclusion Criteria

• if pregnant.
• hemodynamic instability requiring circulatory support.
• need for dose of BCAAs > 1gm/Kg/day or < 0.5 gm/Kg/day.
• severe malnutrition; body mass index (BMI < 16).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Hepatology & Tropical Medicine Research Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

ICU

Consultant of Intensive care medicine, Ph D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NHTMRI

Cairo, , Egypt

Countries

Egypt

References

Mahmoud EIE, Awdallah FF. Prospective randomized, placebo-controlled study: role of branched-chain amino acids infusion as adjunct therapy post-liver surgery for patients in the intensive care unit. BMC Gastroenterol. 2025 Jun 19;25(1):439. doi: 10.1186/s12876-025-03696-3.

Reference Type: DERIVED

PMID: 40537743 (View on PubMed)

Other Identifiers

BCAA

Identifier Type: -

Identifier Source: org_study_id