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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactulose + Rifaximin | Experimental | Continuation of Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route. |
|
| Lactulose therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactulose + Rifaximin | Drug | Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 after enrollment or 7 days after achieving primary endpoint, whichever is shorter. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Tanmay Vyas, MD | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37467180 | Derived | Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2. |
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| ID | Term |
|---|---|
| D065290 | Acute-On-Chronic Liver Failure |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Lactulose | Drug | Continuation of Lactulose therapy for further 48 hours. |
|
| 10 days |
| 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 after enrollment or 7 days after achieving primary endpoint, whichever is shorter. | 10 days |
| Duration of ICU stay. | 10 days after enrollment or 7 days after achieving primary endpoint, whichever is shorter. | 10 days |
| D004066 |
| Digestive System Diseases |
| D000073893 |
| Sugars |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |