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NCT Number: NCT06808009

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

SIRS in ACLF exacerbate adverse effects of ammonia - sarcopenia, infections, immune dysfunction, HE and organ dysfunction Persistent or incident hyperammonemia during first week of hospitalization in patients with ACLF is associated with increased risk of organ failure and death. Prospective studies on the efficacy of ammonia lowering therapies on major adverse liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) in hyperammonemic ACLF patients with no overt HE are limited. In this study we aim to to compare the safety and efficacy of ammonia lowering therapy (goal directed lactulose and rifaximin) compared to SMT to prevent major liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) in hyperammonemic ACLF patients with no overt HE.

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Key information

Conditions

Acute on Chronic Liver Failure Acute-On-Chronic Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location contact

Dr Shreya Singh, MD

CONTACT

[email protected]

01146300000

About this study

Hypothesis: Goal directed ammonia lowering therapy in hyperammonemic ACLF patients with no overt HE leads to reduced incidence of major adverse liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) at day 7, 28 and day 90.

AIM:- To compare the safety and efficacy of ammonia lowering therapy (goal directed lactulose and rifaximin) compared to SMT to prevent major liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) in hyperammonemic ACLF patients with no overt HE.

Study design:

  • A Prospective Randomized Controlled Trial.
  • Single Centre.
  • Open label.
  • Block Randomization will be done , it will be implemented by IWRS method.
  • The study will be conducted in Department of Hepatology, ILBS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Lactulose

Drug

Syp lactulose

Rifaximin

Drug

Rifaximin

Standard Medical Treatment

Other

Standard Medical treatment

Primary outcomes

  1. Proportion of patients achieving composite endpoint target NH3 level < 79.5 mmol/L (135mcg/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.

    Time frame: Day 7

Secondary outcomes

  1. Incidence of bacterial infection at day 4 and 7 in two arms

    Time frame: day 4 and 7

  2. Incidence of overt HE at day 4 and 7 in two arms

    Time frame: day 4 and 7

  3. Proportion of patients with AARC III ACLF at day 4 and 7 in two arms

    Time frame: day 4 and 7

  4. Incidence of new AKI, SBP, Variceal bleed at day 4 and 7 in two arms

    Time frame: day 4 and 7

  5. Proportion of patients with ammonia <79.5 mmol/L(135mcg/dl) at day 1,2,3 and day 7 in 2 arms

    Time frame: day 1,2,3 and day 7

  6. Proportion of patients with >25% and 50% ammonia reduction at day 1,2,3 and day 7 in 2 arms

    Time frame: day 1,2,3 and day 7

  7. Liver related mortality at day 28 and day 90

    Time frame: day 28 and day 90

  8. Changes in markers of systemic inflammation from baseline and day 7 in two arms

    Time frame: day 7

  9. Adverse effect of ammonia lowering therapies

    Time frame: day 90

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Ankur Jindal, DM

CONTACT

[email protected]

01146300000

Dr Shreya Singh, MD

CONTACT

[email protected]

01146300000

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

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.

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