Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy.

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.

Study Overview

• Status: Completed
• Conditions: Acute-On-Chronic Liver Failure
• Intervention / Treatment: Drug: Lactulose + Rifaximin; Drug: Lactulose

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 years and above
2. Patients with ACLF with grade III/IV HE

Exclusion Criteria:

1. Patients with prior decompensation
2. Grade I,II HE
3. Chronic HE
4. CV stroke
5. Patients with ammonia level <70 mcg/dL
6. Patients with Septic shock
7. Pregnant lady

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactulose + Rifaximin; Continuation of Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route.	Drug: Lactulose + Rifaximin; Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route
Active Comparator: Lactulose therapy	Drug: Lactulose; Continuation of Lactulose therapy for further 48 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment.	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 after enrollment or 7 days after achieving primary endpoint, whichever is shorter.	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 after enrollment or 7 days after achieving primary endpoint, whichever is shorter.	10 days
Duration of ICU stay.	10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.	10 days

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Dr Tanmay Vyas, MD, Institute of Liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2014
• Primary Completion (Actual): January 31, 2016
• Study Completion (Actual): January 31, 2016

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Actual): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 7, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin; Lactulose
• Other Study ID Numbers: ILBS-ACLF-HE-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No