NCT02321371

Brief Summary

In this study, all patients with ACLF (Acute on Chronic Liver Failure) with grade III/IV HE (Hepatic Encephalopathy) getting admitted in our institute will be enrolled after the fulfilment of inclusion/exclusion criteria and consent of the patient's attendants. Investigation of the patient (as mentioned in the proforma) will be done. Intervention step 1: liq Lactulose 100 mL stat followed by 30 mL/ hourly through NG/NJ route + Lactulose enema 3rd hourly - till 4 time soft stool is passed, then 30 mL through enteral route 6th hourly (If patient has no bowel sounds, only enema will be given) Intervention step 2: (after 24 hours of introduction of step 1, if no rapid reduction in ammonia to \<70mcg/dL) Randomization to L or R arm R Arm (Addition of Rifaximin) Continuation of Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route L Arm (Lactulose only) Continuation of Lactulose therapy for further 48 hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2016

Completed
Last Updated

February 8, 2018

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

December 17, 2014

Last Update Submit

February 7, 2018

Conditions

Acute-On-Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

  • Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment.

    3 days

Secondary Outcomes (5)

  • Reduction of ammonia level to at least 50% of the baseline value within 72 hours.

    3 days

  • Duration of hepatic encephalopathy post-inclusion.

    10 days

  • Improvement in hepatic encephalopathy from grade III-IV to II-I at any time within 72 hours of treatment.

    3 days

  • Liver disease related and overall mortality.

    10 days

  • Duration of ICU stay.

    10 days

Study Arms (2)

Lactulose + Rifaximin

EXPERIMENTAL

Continuation of Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route.

Drug: Lactulose + Rifaximin

Lactulose therapy

ACTIVE COMPARATOR
Drug: Lactulose

Interventions

Lactulose + RifaximinDRUG

Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route

Lactulose + Rifaximin
LactuloseDRUG

Continuation of Lactulose therapy for further 48 hours.

Lactulose therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and above
  • Patients with ACLF with grade III/IV HE

You may not qualify if:

  • Patients with prior decompensation
  • Grade I,II HE
  • Chronic HE
  • CV stroke
  • Patients with ammonia level \<70 mcg/dL
  • Patients with Septic shock
  • Pregnant lady

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

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

Location

Related Publications (1)

  • Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.

    PMID: 37467180DERIVED

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

LactuloseRifaximin

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Dr Tanmay Vyas, MD

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 22, 2014

Study Start

October 19, 2014

Primary Completion

January 31, 2016

Study Completion

January 31, 2016

Last Updated

February 8, 2018

Record last verified: 2017-01

Locations

IN(1)