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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-19

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute-On-Chronic Liver Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lactulose + Rifaximin

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

Group Type EXPERIMENTAL

Lactulose + Rifaximin

Intervention Type DRUG

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

Lactulose therapy

Group Type ACTIVE_COMPARATOR

Lactulose

Intervention Type DRUG

Continuation of Lactulose therapy for further 48 hours.

Interventions

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Lactulose + Rifaximin

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

Intervention Type DRUG

Lactulose

Continuation of Lactulose therapy for further 48 hours.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No