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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route
Continuation of Lactulose therapy for further 48 hours.
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment.
Time frame: 3 days
Reduction of ammonia level to at least 50% of the baseline value within 72 hours.
Time frame: 3 days
Duration of hepatic encephalopathy post-inclusion.
10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.
Time frame: 10 days
Improvement in hepatic encephalopathy from grade III-IV to II-I at any time within 72 hours of treatment.
Time frame: 3 days
Liver disease related and overall mortality.
10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.
Time frame: 10 days
Duration of ICU stay.
10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter.
Time frame: 10 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.