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Treatment of altered behaviour liver disease patients

To compare the efficacy of broad-spectrum antibiotics with or without rifaximin in the treatment of acute hepatic encephalopathy in critically ill patients - A double blind, randomized controlled trial - ARiE trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041210
Enrollment
184
Registered
2022-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: K729- Hepatic failure, unspecified

Interventions

Intervention1: Rifaximin with antibiotics: Rifaximin 550 mg twice daily Control Intervention1: antibiotics: Only antibiotics as per hospital policy

Sponsors

AIG Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: liver disease patients admitted to the high dependency unit or intensive care unit above the age of 18 with a primary diagnosis of hepatic encephalopathy irrespective of the precipitant.

Exclusion criteria

Exclusion criteria: acute liver failure other causes of encephalopathy (ex: uremic encephalopathy - S. urea > 150) patients with underlying chronic renal failure patients on antidepressants or sedatives underlying neuropsychiatric conditions history of alcohol consumption of less than one week patients who died within 24 hours of admission patients who refused to participate in the study patients below the age of 18

Design outcomes

Primary

MeasureTime frame
To compare the proportion of patients achieving 2-grade reduction of HE (as measured by the West Haven criteria) and/or complete resolution of HE between the two armsTimepoint: during the hospital stay

Secondary

MeasureTime frame
in-hospital mortality in both the armsTimepoint: during the hospital stay;duration of hospital stay in both armsTimepoint: duration of hospital stay;incidence of nosocomial (new-onset in-hospital) infectionTimepoint: during the hospital stay;time taken for resolution of infection (if any) Timepoint: during the hospital stay;Time taken to resolution of HE in both arms Timepoint: during the hospital stay;To compare endotoxin levels at diagnosis and at the resolution of HE between both arms Timepoint: during the hospital stay

Countries

India

Contacts

Public ContactAnand V Kulkarni

AIG Hospitals

dranand.v@aighospitals.com

Outcome results

None listed

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