NHTMRI
Cairo, Egypt
NCT Number: NCT03448848
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).
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Cairo, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 in a volume equal to the study drug
Time frame: within one week post liver surgery
improvement of liver function tests, AsT
Time frame: within one week post liver surgery
improvement of ALT
Time frame: within one week post surgery
Improvement of total bilirubin
Time frame: within one week post surgery
improvement of alkaline phosphatase
Time frame: within one week post surgery
improvement of prothrombin time
Time frame: within one week post surgery
Improvement with BCAA infusion
Time frame: within one week post surgery
improvement with BCAA infusion
Time frame: 30 days post surgery
occurrence of infections post surgery
Time frame: 30 days
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.
Time frame: within two weeks post surgery
Length of ICU stay in days
Time frame: within two weeks post surgery
Length of hospital stay in days
Time frame: 28 day
28-day mortality
National Hepatology & Tropical Medicine Research Institute
Other Gov
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