To explore potential therapies for reducing ammonia levels in patients with ACLF (liver disease).

Goal 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. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080857

Enrollment

Registered

2025-02-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: lactulose and rifaximin: T. Rifaximin 550 mg po BD Syp Lactulose to ensure 2-3 motions. Route: Oral Control Intervention1: Standard Medical Treatment: Routine medicines Albumin Iv ant

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving composite endpoint target NH3 level less than 79.5 mmol per L (135mcg per dl) and /or Incidence of major adverse liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) at day 7 in two arms.Timepoint: Day 7	—

Secondary

Measure	Time frame
Incidence of bacterial infection, overt HE and new AKI, SBP, Variceal bleed.Timepoint: Day 4 & 7;Proportion of patients with AARC III ACLF at day 4 and 7 in two armsTimepoint: day 4 and 7;Proportion of patients with ammonia less than 79.5 mmol per L(135mcg per dl)and with more than 25% and 50% ammonia reduction at day 1,2,3 and day 7 in 2 armsTimepoint: day 1,2,3 and day 7 in 2 arms;Liver related mortality at day 28 and day 90Timepoint: day 28 and day 90;Changes in markers of systemic inflammation from baseline and day 7 in two armsTimepoint: day 7 in two arms;Adverse effect of ammonia lowering therapiesTimepoint: Day 90	—

Measure

Time frame

Incidence of bacterial infection, overt HE and new AKI, SBP, Variceal bleed.Timepoint: Day 4 & 7;Proportion of patients with AARC III ACLF at day 4 and 7 in two armsTimepoint: day 4 and 7;Proportion of patients with ammonia less than 79.5 mmol per L(135mcg per dl)and with more than 25% and 50% ammonia reduction at day 1,2,3 and day 7 in 2 armsTimepoint: day 1,2,3 and day 7 in 2 arms;Liver related mortality at day 28 and day 90Timepoint: day 28 and day 90;Changes in markers of systemic inflammation from baseline and day 7 in two armsTimepoint: day 7 in two arms;Adverse effect of ammonia lowering therapiesTimepoint: Day 90

—

Countries

India

Contacts

Public ContactDr Ankur jindal

Institute of Liver and Biliary Sciences

ankur.jindal3@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026