Recruiting soon

Ammonia Lowering Therapy for Hyperammonemic ACLF Without Overt HE

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Lactulose

+ Rifaximin

+ Standard Medical treatment

DrugOther
Who is being recruted

Digestive System Diseases+3

+ Liver Diseases

+ Liver Failure

From 18 to 70 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorInstitute of Liver and Biliary Sciences, India
Study ContactDr Shreya Singh, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleGoal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Related Outcomes (GOAL Trial)- A Randomized Controlled Trial
NCT06808009
Principal SponsorInstitute of Liver and Biliary Sciences, India
Study ContactDr Shreya Singh, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Digestive System DiseasesLiver DiseasesLiver FailureLiver Failure, AcuteHepatic InsufficiencyAcute-On-Chronic Liver Failure

Criteria

4 inclusion criteria required to participate
Age 18-70 years

ACLF as per APASL criteria (AARC grade I/II)

Baseline ammonia levels of ≥135ug/dl or 79.5umol/l

Given informed consent

1 exclusion criteria prevent from participating
1. Overt HE 2. AARC grade III 3. Confirmed or suspected bacterial infection 4. Extrahepatic organ failure 5. Renal dysfunction lasting for more than 48 hours or need for vasoconstrictors 6. Paralytic ileus 7. Patients with hepatocellular carcinoma beyond Milan criteria or any other neoplastic disorder 8. Pregnant and lactating women 9. Use of lactulose, rifaximin or LOLA in past 48h 10. Uncontrolled DM, HT, CAD 11. Patients with allergy or other contraindications of the used drugs

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
T. Rifaximin 550 mg po bd Syp Lactulose to ensure 2-3 motions

Group II

Active Comparator
Routine medicines, Albumin Iv antibiotics,Protein powder , branched chain amino acids

Study 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

Suspended

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, IndiaOpen Institute of Liver & Biliary Sciences (ILBS) in Google Maps
Recruiting soonOne Study Center