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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Acute-On-Chronic Liver Failure

Treatments: Drug: Lactulose; Drug: Lactulose + Rifaximin

Study type: Interventional

Funder types: Other

Identifiers

NCT02321371

ILBS-ACLF-HE-01

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Lactulose + Rifaximin

Experimental group

Description:

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

Treatment:

Drug: Lactulose + Rifaximin

Lactulose therapy

Active Comparator group

Treatment:

Drug: Lactulose