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The purpose of this study is to evaluate whether the use of polyethylene glycol is superior and more safe in treating hepatic encephalopathy compared to lactulose and also to determine if treatment with polyethylene glycol will reduce the duration of hospital stay.
Hepatic encephalopathy is the occurrence altered level of consciousness as a result of cirrhosis and liver failure. Main treatment goal for hepatic encephalopathy is to eliminate the precipitating factor and to decrease circulating ammonia level. Current standard for treating HE is treatment with Lactulose. Lactulose are metabolized by colonic bacteria to byproducts which cause catharsis and reduces pH, thereby inhibiting ammonia absorption. However, there is limited evidence available to demonstrate the efficacy. Studies on animal model have suggested that polyethylene glycol 3350-electrolyte solution (GOLYTELY) is effective in clearing gut bacteria and reducing the ammoniagenesis in colon. Recently published study by Robert Rahimi, University of Texas Southwestern Medical Center found that polyethylene glycol is more effective in improving HE over the first 24 hours compared to lactulose and also may reduce duration of hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactulose | Other | per standard of care |
|
| polyethylene glycol 3350 (Golytely) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactulose | Drug | If randomized to this group, subjects will receive 10 - 30 grams of lactulose per standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of cognition | Subjects will be evaluated every 24hr from the time of enrollment to assess for improvement of cognition until back to baseline and/or grade 0 based on HESA scare | 24 hours from the time of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospital stay | To determine if treatment with polyethylene glycol compared to lactulose will reduce the duration of hospital stay | From time of admission to time of discharge an approximate length of seven days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Smruti R Mohanty, MD | New York Presbyterian Brooklyn Methodist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D005355 | Fibrosis |
| D048550 | Hepatic Insufficiency |
| D008103 | Liver Cirrhosis |
| D001925 | Brain Damage, Chronic |
| D003693 | Delirium |
| D004660 | Encephalitis |
| D020258 | Neurotoxicity Syndromes |
| D017093 | Liver Failure |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D010335 | Pathologic Processes |
| D003221 | Confusion |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| C000595212 | polyethylene glycol 3350 |
| C033608 | Golytely |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Polyethylene Glycol 3350 | Drug | If subject is randomized to this group, one time dose of one gallon polyethylene glycol 3350 will be given at the time of enrollment |
|
|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020805 | Central Nervous System Viral Diseases |
| D014777 | Virus Diseases |
| D002494 | Central Nervous System Infections |
| D011041 | Poisoning |
| D019966 | Substance-Related Disorders |
| D000090862 | Neuroinflammatory Diseases |
| D064419 | Chemically-Induced Disorders |
| D007239 | Infections |
| D000073893 |
| Sugars |