Acute-On-Chronic Liver Failure
Conditions
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.
Interventions
DRUGLactulose + Rifaximin
Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route
DRUGLactulose
Continuation of Lactulose therapy for further 48 hours.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment. | 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
India
Outcome results
None listed