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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study | Experimental |
| |
| control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCAA preparation Intravenous infusion | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| effect on liver function tests | improvement of liver function tests, AsT | within one week post liver surgery |
| effect on liver function tests | improvement of ALT | within one week post liver surgery |
| effect on liver function tests | Improvement of total bilirubin | within one week post surgery |
| effect on liver function tests | improvement of alkaline phosphatase | within one week post surgery |
| effect on liver function tests | improvement of prothrombin time | within one week post surgery |
| Child-Pugh score post-surgery. | Improvement with BCAA infusion | within one week post surgery |
| SOFA score post-surgery | improvement with BCAA infusion | within one week post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day infectious morbidity Infectious morbidity | occurrence of infections post surgery | 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHTMRI | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40537743 | Derived | Mahmoud EIE, Awdallah FF. Prospective randomized, placebo-controlled study: role of branched-chain amino acids infusion as adjunct therapy post-liver surgery for patients in the intensive care unit. BMC Gastroenterol. 2025 Jun 19;25(1):439. doi: 10.1186/s12876-025-03696-3. |
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| sterile normal saline | Drug | sterile normal saline in a volume equal to the study drug |
|
| 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 | 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 | within two weeks post surgery |
| mortality | 28-day mortality | 28 day |