Liver Function Post BCAA InfusionNCT03448848
Role of Branched-chain Amino Acids Infusion as Adjunct Therapy Post Liver Surgery for Patients in Intensive Care Unit
A study testing BCAA preparation Intravenous infusion and sterile normal saline in people with Liver Function Post BCAA Infusion, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Function Post BCAA Infusion
- What is being tested?
- BCAA preparation Intravenous infusion and sterile normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2018to 10 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Liver Function Post BCAA Infusion
- Being tested
- BCAA preparation Intravenous infusion, sterile normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAA preparation Intravenous infusionDrug
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 salineDrug
sterile normal saline in a volume equal to the study drug
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | Not described Receives: Drug: BCAA preparation Intravenous infusion |
| control | Placebo comparator | Not described Receives: Drug: sterile normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on liver function tests
improvement of liver function tests, AsT
Measured: within one week post liver surgery
effect on liver function tests
improvement of ALT
Measured: within one week post liver surgery
effect on liver function tests
Improvement of total bilirubin
Measured: within one week post surgery
effect on liver function tests
improvement of alkaline phosphatase
Measured: within one week post surgery
effect on liver function tests
improvement of prothrombin time
Measured: within one week post surgery
Child-Pugh score post-surgery.
Improvement with BCAA infusion
Measured: within one week post surgery
SOFA score post-surgery
improvement with BCAA infusion
Measured: within one week post surgery
Secondary outcomes (5)
30-day infectious morbidity Infectious morbidity
occurrence of infections post surgery
Measured: 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.
Measured: 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
Measured: 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
Measured: within two weeks post surgery
mortality
28-day mortality
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start15 Mar 2018
- Primary completion27 Aug 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Function Post BCAA InfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Hepatology & Tropical Medicine Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ICU, National Hepatology & Tropical Medicine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448848
- Sponsor's protocol ID
- BCAA
- Status last verified
- Feb 2021
- First submitted
- 2 Jan 2018
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40537743
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Branched-chain Amino Acids Infusion as Adjunct Therapy Post Liver Surgery for Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03448848
- Acronym / sponsor ID
- BCAA
- Conditions
- Liver Function Post BCAA Infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Hepatology & Tropical Medicine Research InstituteOther government
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Drug: BCAA preparation Intravenous infusion |
| control | Placebo comparator | Drug: sterile normal saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCAA preparation Intravenous infusionBCAA 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 | Drug | study |
| sterile normal salinesterile normal saline in a volume equal to the study drug | Drug | control |
Primary outcome
effect on liver function tests
Time frame: within one week post liver surgery
improvement of liver function tests, AsT
effect on liver function tests
Time frame: within one week post liver surgery
improvement of ALT
effect on liver function tests
Time frame: within one week post surgery
Improvement of total bilirubin
effect on liver function tests
Time frame: within one week post surgery
improvement of alkaline phosphatase
effect on liver function tests
Time frame: within one week post surgery
improvement of prothrombin time
Child-Pugh score post-surgery.
Time frame: within one week post surgery
Improvement with BCAA infusion
SOFA score post-surgery
Time frame: within one week post surgery
improvement with BCAA infusion
5 secondary outcomes
30-day infectious morbidity Infectious morbidity
Time frame: 30 days post surgery
non infectious morbidity
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.
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.
Time frame: within two weeks post surgery
mortality
Time frame: 28 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 40537743Mahmoud 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCAA preparation Intravenous infusion and sterile normal saline in people with Liver Function Post BCAA Infusion, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect on liver function tests (time frame: within one week post liver surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.