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The current standard of care for patients with HE includes non-absorbable disaccharides(lactulose);The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose.The exact mode of action by lactulose is thought to be the conversion to lactic acid and acetic acid by colonic bacteria resulting in acidification of the gut lumen. This favors conversion of ammonia (NH3) to ammonium (NH4+), which is relatively membrane impermeable; therefore, less ammonia is absorbed by the colon. Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. Nonabsorbable disaccharides also work as a cathartic, clearing the gut of ammonia before it can be absorbed.
Polyethylene glycol electrolyte solution (PEG) is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. It is used safely to clean the bowel before colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactulose | Active Comparator | (20 to 30 g administered orally or by nasogastric tube (3 or more doses within 24 hours) or 200 g by rectal tube if oral intake was not possible or inadequate. |
|
| Polyeyhylene Glychol | Active Comparator | Polyethylene Glycol 3sachets if patient <75Kg over 3 hours or 4 sachets if patient >75Kg over 4 hours dministered orally or via a nasogastric tube (each sachet 64g/25Kg must be dissolved in one liter of water) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactulose | Drug | (lactulose) (20 to 30 g administered orally or by nasogastric tube (3 or more doses within 24 hours) or 200 g by rectal tube if oral intake was not possible or inadequate |
| Measure | Description | Time Frame |
|---|---|---|
| 1 or more in HE grade improvement at 24 hours | HE grade improvement at 24 hours | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to HE resolution | Time to Hepatic encephalopathy resolution | 2 weeks |
| Overall length of stay | Overall length of stay | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sherief Abd-Elsalam, MD | Contact | 00201095159522 | Sheriefabdelsalam@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Hanan Soliman, MD | Tanta University Faculty of Medicine | Principal Investigator |
| Amany Abd El-Rahim Abdin, MD | Tanta university Faculty of Pharmacy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tropical medicine dept.-Tanta university hospital | Recruiting | Cairo | Egypt |
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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 |
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
| Polyethylene Glycol | Drug | PEG as single dose of (3sachets if patient <75Kg over 3 hours or 4 sachets if patient >75Kg over 4 hours) dministered orally or via a nasogastric tube (each sachet 64g/25Kg must be dissolved in one liter of water). |
|
| Samah Mosaad Soliman, MD |
| Tanta University Faculty of Medicine |
| Study Director |
| Hala Hany Shehata, Msc | Tanta University Faculty of Medicine | Study Chair |
| Sherief Abd-Elsalam, MD | Tanta University Faculty of Medicine | Study Chair |
| 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 |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |