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

Not Applicable

Completed

• Conditions: Acute-On-Chronic Liver Failure
• Interventions: Drug: Lactulose + Rifaximin; Drug: Lactulose

• Registration Number: NCT02321371
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-19
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-22
• Primary Completion: 2016-01-31
• Study Completion: 2016-01-31
• Status Verified: 2017-01
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactulose + Rifaximin	Lactulose + Rifaximin	Continuation of Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route.
Lactulose therapy	Lactulose	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India