Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Related Outcomes (GOAL Trial)

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Feb 3, 2025

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ClinConnect Summary

The GOAL Trial is a research study looking at a treatment for patients with Acute on Chronic Liver Failure (ACLF) who have high levels of ammonia in their blood but do not show clear signs of brain issues, known as overt hepatic encephalopathy (HE). High ammonia levels can lead to serious health problems, including organ failure and infections. This trial aims to compare a specific ammonia-lowering treatment (using medications like lactulose and rifaximin) against standard medical treatment to see if it can help reduce the risk of severe liver-related complications, such as worsening organ function or death.

To participate in the trial, patients must be between 18 and 70 years old, diagnosed with ACLF, and have elevated ammonia levels. They should not have any signs of overt HE or other serious infections. If eligible, participants can expect to receive either the ammonia-lowering therapy or standard treatment during their hospital stay. It’s important to know that the trial is not yet recruiting participants, so those interested will need to wait until it begins.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-70 years
• • 2. ACLF as per APASL criteria (AARC grade I/II)
• • 3. Baseline ammonia levels of ≥135ug/dl or 79.5umol/l
• • 4. Given informed consent
• Exclusion Criteria:
• • 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