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

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).

Study Overview

• Status: Completed
• Conditions: Liver Function Post BCAA Infusion
• Intervention / Treatment: Drug: BCAA preparation Intravenous infusion; Drug: sterile normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • NHTMRI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control	Drug: sterile normal saline; sterile normal saline in a volume equal to the study drug
Experimental: study	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect on liver function tests	improvement of liver function tests, AsT	within one week post liver surgery
effect on liver function tests	improvement of ALT	within one week post liver surgery
effect on liver function tests	Improvement of total bilirubin	within one week post surgery
effect on liver function tests	improvement of alkaline phosphatase	within one week post surgery
effect on liver function tests	improvement of prothrombin time	within one week post surgery
Child-Pugh score post-surgery.	Improvement with BCAA infusion	within one week post surgery
SOFA score post-surgery	improvement with BCAA infusion	within one week post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day infectious morbidity Infectious morbidity	occurrence of infections post surgery	30 days post surgery
non infectious morbidity	occurrence of hepatic encephalopathy, ruptured esophageal varices, ascites requiring diuretic agent for control, wound dehiscence, intra-abdominal bleeding, intestinal obstruction, renal failure, pleural effusion, need mechanical ventilation, blood sugar control & nutritional status change.	30 days
ICU stay. length of ICU stay, length of hospital stay & 28day mortality. length of ICU stay, length of hospital stay & 28day mortality. length of ICU stay, length of hospital stay & 28day mortality.	Length of ICU stay in days	within two weeks post surgery
Hospital stay. length of ICU stay, length of hospital stay & 28day mortality. length of ICU stay, length of hospital stay & 28day mortality. length of ICU stay, length of hospital stay & 28day mortality.	Length of hospital stay in days	within two weeks post surgery
mortality	28-day mortality	28 day

Collaborators and Investigators

• Sponsor: National Hepatology & Tropical Medicine Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): August 27, 2020
• Study Completion (Actual): September 10, 2020

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: BCAA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No