NCT03448848

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2.5 years

First QC Date

January 2, 2018

Last Update Submit

February 19, 2021

Conditions

Liver Function Post BCAA Infusion

Outcome Measures

Primary Outcomes (7)

  • 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

Secondary Outcomes (5)

  • 30-day infectious morbidity Infectious morbidity

    30 days post surgery

  • non infectious morbidity

    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.

    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.

    within two weeks post surgery

  • mortality

    28 day

Study Arms (2)

study

EXPERIMENTAL
Drug: BCAA preparation Intravenous infusion

control

PLACEBO COMPARATOR
Drug: sterile normal saline

Interventions

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

study
sterile normal salineDRUG

sterile normal saline in a volume equal to the study drug

control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHTMRI

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 40537743DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of Intensive care medicine, Ph D

Study Record Dates

First Submitted

January 2, 2018

First Posted

February 28, 2018

Study Start

March 15, 2018

Primary Completion

August 27, 2020

Study Completion

September 10, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

EG(1)