Clinical trial NCT03448848: Role of Branched-chain Amino Acids Infusion as Adjunct Therapy Post Liver Surgery for Patients in Intensive Care Unit
Official title: Role of Branched-chain Amino Acids Infusion as Adjunct Therapy Post Liver Surgery for Patients in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Function Post BCAA Infusion
Lead sponsor: National Hepatology & Tropical Medicine Research Institute
Sponsor class: OTHER_GOV
First posted: 2018-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: effect on liver function tests
timeFrame: within one week post liver surgery
measure: effect on liver function tests
timeFrame: within one week post liver surgery
measure: effect on liver function tests
timeFrame: within one week post surgery
measure: effect on liver function tests
timeFrame: within one week post surgery
measure: effect on liver function tests
timeFrame: within one week post surgery
measure: Child-Pugh score post-surgery.
timeFrame: within one week post surgery
measure: SOFA score post-surgery
timeFrame: within one week post surgery
Secondary outcomes:
measure: 30-day infectious morbidity Infectious morbidity
timeFrame: 30 days post surgery
measure: non infectious morbidity
timeFrame: 30 days
measure: 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.
timeFrame: within two weeks post surgery
measure: 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.
timeFrame: within two weeks post surgery
measure: mortality
timeFrame: 28 day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NHTMRI
Study officials:
References: