An interventional study of Lactulose and Rifaximin in Acute on Chronic Liver Failure, sponsored by Institute of Liver and Biliary Sciences, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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.
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:
173 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 59 are open to participants now.
This study's planned enrollment of 90 is above the median of 72 across 101 interventional studies indexed under Acute-On-Chronic Liver Failure.
Browse Acute-On-Chronic Liver Failure studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
T. Rifaximin 550 mg po bd Syp Lactulose to ensure 2-3 motions
Drug: Lactulose · Drug: Rifaximin
Routine medicines, Albumin Iv antibiotics,Protein powder , branched chain amino acids
Other: Standard Medical treatment
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
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
Plan to share: Undecided
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Studies of the drugs tested here: Lactulose · Rifaximin
Acute-On-Chronic Liver Failure →
Institute of Liver and Biliary Sciences, India →