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Completed

NCT Number: NCT03448848

Role of Branched-chain Amino Acids Infusion as Adjunct Therapy Post Liver Surgery for Patients in Intensive Care Unit

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHTMRI

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Sterile normal saline

Drug

sterile normal saline in a volume equal to the study drug

Primary outcomes

  1. effect on liver function tests

    Time frame: within one week post liver surgery

    improvement of liver function tests, AsT

  2. effect on liver function tests

    Time frame: within one week post liver surgery

    improvement of ALT

  3. effect on liver function tests

    Time frame: within one week post surgery

    Improvement of total bilirubin

  4. effect on liver function tests

    Time frame: within one week post surgery

    improvement of alkaline phosphatase

  5. effect on liver function tests

    Time frame: within one week post surgery

    improvement of prothrombin time

  6. Child-Pugh score post-surgery.

    Time frame: within one week post surgery

    Improvement with BCAA infusion

  7. SOFA score post-surgery

    Time frame: within one week post surgery

    improvement with BCAA infusion

Secondary outcomes

  1. 30-day infectious morbidity Infectious morbidity

    Time frame: 30 days post surgery

    occurrence of infections post surgery

  2. non infectious morbidity

    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.

  3. 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.

    Time frame: within two weeks post surgery

    Length of ICU stay in days

  4. 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.

    Time frame: within two weeks post surgery

    Length of hospital stay in days

  5. mortality

    Time frame: 28 day

    28-day mortality

Sponsors and collaborators

Lead sponsor

National Hepatology & Tropical Medicine Research Institute

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2018
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.