PGIMER
Chandigarh, 160012, India
NCT Number: NCT04238416
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Chandigarh, 160012, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
As the study was carried out during the peak of the COVID-19, patients who developed COVID-19 after randomization were excluded from the analysis as they were shifted to dedicated COVID-19 ICU's.
Intravenous branched chain amino acids will be given for 3 days to patients in experimental arm
Oral lactulose will be given to patients in both arms
Time frame: At day day 28
All cause Mortality assessment
Time frame: 72 hours
Improvement in hepatic encephalopathy
Time frame: 48 and 72 hours
Time frame: 30 days
Time frame: 30 days
Time frame: 72 hours
Post Graduate Institute of Medical Education and Research, Chandigarh
Other
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
Acronym: BCAA-ACLF
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.
Published trials that share one or more normalized conditions with this study.
NCT05700695
Acute-On-Chronic Liver Failure, Brain Diseases
Chandigarh, India
View Trial DetailsNCT04058327
Acute-On-Chronic Liver Failure, Brain Diseases
Wuhan, Hubei, China
View Trial DetailsNCT05425316
Brain Diseases, Brain Diseases, Metabolic
Ann Arbor, Michigan, United States
View Trial DetailsNCT07480096
Brain Diseases, Brain Diseases, Metabolic
Jakarta, DKI Jakarta, Indonesia
View Trial Details