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).
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
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
NHTMRI
Cairo, Egypt
effect on liver function tests
improvement of liver function tests, AsT
Time frame: within one week post liver surgery
effect on liver function tests
improvement of ALT
Time frame: within one week post liver surgery
effect on liver function tests
Improvement of total bilirubin
Time frame: within one week post surgery
effect on liver function tests
improvement of alkaline phosphatase
Time frame: within one week post surgery
effect on liver function tests
improvement of prothrombin time
Time frame: within one week post surgery
Child-Pugh score post-surgery.
Improvement with BCAA infusion
Time frame: within one week post surgery
SOFA score post-surgery
improvement with BCAA infusion
Time frame: within one week post surgery
30-day infectious morbidity Infectious morbidity
occurrence of infections post surgery
Time frame: 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.
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Time frame: 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
Time frame: 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
Time frame: within two weeks post surgery
mortality
28-day mortality
Time frame: 28 day