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lack of funds
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Study Design- Randomized Controlled trial Duration of enrolment-Feb-2016 to December 2017 Sample size-120 patients Methodology We will include consecutive with advanced hepatic encephalopathy not responding to treatment of precipitants and on treatment with Lactulose and Rifaximin for 48 hours .
Two groups will be divided. One arm -Lactulose and Rifaximin will be continued Second Arm - Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactulose with Rifaximin | Active Comparator |
| |
| Plasmapheresis | Experimental | Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactulose | Drug | Lactulose 20 mL |
| |
| Rifaximin |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution in Hepatic Encephalopathy by 2 grades in both groups | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Hepatic Encephalopathy in both groups | 2 years | |
| Number of days of mechanical ventilation in both groups | 2 years | |
| Survival in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| D000078262 | Rifaximin |
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Drug |
Rifaximin 550 BD |
|
| Plasmapheresis | Biological | Plasmapheresis 8 hrly duration |
|
| 28 days |
| Proportion of patients with Systemic inflammatory response syndrome (SIRS) or sepsis as precipitants of Hepatic encephalopathy in both groups. | 2 years |
| Proportion of patients with failure of standard medical therapy in both groups. | 48 hours |
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic 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 |
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |