Ammonia Lowering Therapy for Hyperammonemic ACLF Without Overt HE
Lactulose
+ Rifaximin
+ Standard Medical treatment
Digestive System Diseases+3
+ Liver Diseases
+ Liver Failure
Treatment Study
Summary
Study start date: February 5, 2025
Actual date on which the first participant was enrolled.This study focuses on patients with acute-on-chronic liver failure (ACLF) who have high ammonia levels in their blood but do not show obvious signs of hepatic encephalopathy (HE), a brain condition caused by liver disease. The trial aims to find out if specific treatments to lower ammonia levels, using medications like lactulose and rifaximin, can reduce severe liver-related complications such as severe liver failure, infections, worsening of brain function, or death. These outcomes are evaluated over three time points: day 7, day 28, and day 90 after starting the treatment. This research is important because it may offer a way to improve the health and survival of patients with this severe liver condition. In this study, participants are randomly divided into groups to receive either the ammonia-lowering treatment or standard medical treatment. The study is conducted openly, meaning both the doctors and participants know which treatments are being given. The effectiveness and safety of the treatments are closely monitored by checking for any major liver-related complications. The study takes place at a single medical center, and results are expected to guide better treatment strategies for managing high ammonia levels in patients with ACLF without apparent HE symptoms.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, IndiaOpen Institute of Liver & Biliary Sciences (ILBS) in Google Maps