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

Liver Function Post BCAA Infusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448848
• Other study ID #: BCAA
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: September 10, 2020

Study information

• Verified date: February 2021
• Source: National Hepatology & Tropical Medicine Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 10, 2020
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Liver Function Post BCAA Infusion

Intervention

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
• sterile normal saline
sterile normal saline in a volume equal to the study drug

Locations

Country	Name	City	State
Egypt	NHTMRI	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Hepatology & Tropical Medicine Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect on liver function tests	improvement of liver function tests, AsT	within one week post liver surgery
Primary	effect on liver function tests	improvement of ALT	within one week post liver surgery
Primary	effect on liver function tests	Improvement of total bilirubin	within one week post surgery
Primary	effect on liver function tests	improvement of alkaline phosphatase	within one week post surgery
Primary	effect on liver function tests	improvement of prothrombin time	within one week post surgery
Primary	Child-Pugh score post-surgery.	Improvement with BCAA infusion	within one week post surgery
Primary	SOFA score post-surgery	improvement with BCAA infusion	within one week post surgery
Secondary	30-day infectious morbidity Infectious morbidity	occurrence of infections post surgery	30 days post surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	mortality	28-day mortality	28 day