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

ConditionAcute on Chronic Liver Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstitute of Liver and Biliary Sciences, India

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lactulose

    Drug

    Syp lactulose

  • Rifaximin

    Drug

    Rifaximin

  • Standard Medical treatment

    Other intervention

    Standard Medical treatment

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: lactulose and rifaximinExperimental treatment 2 interventions
Group B: Standard Medical TreatmentActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Liver and Biliary Sciences, India

Lead sponsor

Source ClinicalTrials.gov

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