Menu
Not yet recruiting NCT06808009

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

No phase Interventional Acute on Chronic Liver Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lactulose, Rifaximin, Standard Medical treatment.
Who it may be relevant to
Registry conditions: Acute on Chronic Liver Failure. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Detailed description

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.

Interventions

  • Drug Lactulose
    Syp lactulose
  • Drug Rifaximin
    Rifaximin
  • Other Standard Medical treatment
    Standard Medical treatment

Primary outcome measures

  • 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 outcome measures (9)
  • Incidence of bacterial infection at day 4 and 7 in two arms [Time frame: day 4 and 7]
  • Incidence of overt HE at day 4 and 7 in two arms [Time frame: day 4 and 7]
  • Proportion of patients with AARC III ACLF at day 4 and 7 in two arms [Time frame: day 4 and 7]
  • Incidence of new AKI, SBP, Variceal bleed at day 4 and 7 in two arms [Time frame: day 4 and 7]
  • 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]
  • 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]
  • Liver related mortality at day 28 and day 90 [Time frame: day 28 and day 90]
  • Changes in markers of systemic inflammation from baseline and day 7 in two arms [Time frame: day 7]
  • Adverse effect of ammonia lowering therapies [Time frame: day 90]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

India · 1 center
  • Institute of Liver & Biliary Sciences (ILBS) — New Delhi

Identifiers

NCT: NCT06808009 · ILBS-ACLF-23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗