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Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF (BCAA-ACLF)

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ClinicalTrials.gov Identifier: NCT04238416
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Madhumita Premkumar, Postgraduate Institute of Medical Education and Research

Brief Summary:
This study analyses the effect of intravenous branched chain amino acids (BCAA) on overt HE in patients with ACLF. The investigators plan to study the efficacy of combining intravenous BCAA with lactulose versus lactulose alone in the medical management of overt HE in patients with ACLF and its impact on overall survival and improvement in grade of HE.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Acute-On-Chronic Liver Failure Drug: Branched chain amino acid Drug: Lactulose Phase 1

Detailed Description:
Acute on chronic liver failure (ACLF) is a distinct clinical entity in the spectrum of chronic liver disease associated with high short term mortality. Hepatic encephalopathy (HE) is commonly seen in patients with ACLF and its treatment mainly involves non-absorbable disaccharides (lactulose/lactitol).Treatment of HE in ACLF is based on extrapolation of data available from cirrhotic patients. No studies have compared different treatment options for HE in patients with ACLF.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective interventional cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Lactulose Plus Intravenous Branched Chain Amino Acids Versus Lactulose Alone in Patients of Acute on Chronic Liver Failure With Overt Hepatic Encephalopathy: A Prospective Randomized Clinical Trial
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IV BCAA + Lactulose
IV Branched Chain Amino Acids - 500mL once daily for 3 days plus Lactulose
Drug: Branched chain amino acid
Intravenous branched chain amino acids will be given for 3 days to patients in experimental arm

Drug: Lactulose
Oral lactulose will be given to patients in both arms

Active Comparator: Lactulose alone
Oral Lactulose alone
Drug: Lactulose
Oral lactulose will be given to patients in both arms




Primary Outcome Measures :
  1. Improvement of Survival [ Time Frame: At day day 28 ]
    All cause Mortality assessment

  2. Improvement of encephalopathy by ≥ 1 grade [ Time Frame: 72 hours ]
    Improvement in hepatic encephalopathy


Secondary Outcome Measures :
  1. Reduction in level of ammonia [ Time Frame: 48 and 72 hours ]
  2. Reduction of consciousness recovery time among survivors [ Time Frame: 30 days ]
  3. Prolongation of time to death among non-survivors [ Time Frame: 30 days ]
  4. Prevention/reduction of cerebral edema based on optic nerve sheath diameter [ Time Frame: 72 hours ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-75 years
  2. Either gender
  3. Patients with ACLF (CANONIC definition) of any aetiology with HE ≥grade 2 as per West-Haven Criteria

Exclusion Criteria:

  1. Those who do not consent to participate in the study
  2. Patients with structural brain lesions or stroke
  3. Inability to obtain informed consent from patient or relatives
  4. Severe preexisting cardiopulmonary disease
  5. Renal dysfunction (S. Creatinine ≥ 2mg/dL)
  6. Pregnancy/Lactation
  7. Post liver transplant patients
  8. HIV infection
  9. Patients who are on psychoactive drugs, like sedatives or antidepressants
  10. Patients who are too sick to carry out the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238416


Contacts
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Contact: Madhumita Premkumar, MD, DM +919540951061 drmadhumitap@gmail.com

Locations
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India
PGIMER Recruiting
Chandigarh, India, 160012
Contact: Madhumita Premkumar, MD, DM         
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Madhumita Premkumar, MD, DM Postgraduate Institute of Medical Education and Research
Publications of Results:
Other Publications:

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Responsible Party: Madhumita Premkumar, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT04238416    
Other Study ID Numbers: IEC-08/2019-1336
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Madhumita Premkumar, Postgraduate Institute of Medical Education and Research:
branched chain amino acids
hepatic encephalopathy
lactulose
acute on chronic liver failure
bispectral index
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Hepatic Encephalopathy
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Liver Failure, Acute
Lactulose
Gastrointestinal Agents