NCT03448848

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Hepatology & Tropical Medicine Research Institute · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DRUG	sterile normal saline	sterile normal saline in a volume equal to the study drug

Timeline

• Start date: 2018-03-15
• Primary completion: 2020-08-27
• Completion: 2020-09-10
• First posted: 2018-02-28
• Last updated: 2021-02-21

Locations

1 site across 1 country: Egypt