Liver Function Post BCAA Infusion
Conditions
Brief 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.
Interventions
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
Sponsors
Study design
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effect on liver function tests | within one week post liver surgery | improvement of liver function tests, AsT |
| Child-Pugh score post-surgery. | within one week post surgery | Improvement with BCAA infusion |
| SOFA score post-surgery | within one week post surgery | improvement with BCAA infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | within two weeks post surgery | Length of hospital stay in days |
| 30-day infectious morbidity Infectious morbidity | 30 days post surgery | occurrence of infections post surgery |
| mortality | 28 day | 28-day mortality |
| non infectious morbidity | 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. |
| 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. | within two weeks post surgery | Length of ICU stay in days |
Countries
Egypt