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

• Status: Completed
• Trial end date: 2016-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Lactulose; Rifamycins; Rifaximin

Criteria

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