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

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Completed

CT.gov ID

NCT02321371

Collaborator

(none)

Enrollment

Location

Arms

15.4

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute-On-Chronic Liver Failure	Drug: Lactulose + Rifaximin Drug: Lactulose	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Actual Study Start Date :

Oct 19, 2014

Actual Primary Completion Date :

Jan 31, 2016

Actual Study Completion Date :

Jan 31, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment. [3 days]

Secondary Outcome Measures

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]
10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.
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]
10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.
Duration of ICU stay. [10 days]
10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver & Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

Principal Investigator: Dr Tanmay Vyas, MD, Institute of Liver and Biliary Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT02321371

Other Study ID Numbers:

ILBS-ACLF-HE-01

First Posted:

Dec 22, 2014

Last Update Posted:

Feb 8, 2018

Last Verified:

Jan 1, 2017

Additional relevant MeSH terms:

Liver Failure

Hepatic Insufficiency

End Stage Liver Disease

Acute-On-Chronic Liver Failure

Rifaximin

Lactulose

Study Results

No Results Posted as of Feb 8, 2018