Randomized Trial Comparing The Efficacy of PEG (Polyethylene Glycol) Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 1 or more in HE grade improvement at 24 hours
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult Patients with Overt Hepatic Encephalopathy.
Exclusion Criteria
- •Patients with active GIT bleeding.
- •Patients with history of bowel obstruction, perforation.
- •Patients with history of allergy to PEG.
- •Treatment with rifaximin or neomycin in the previous 7 days.
- •Patients with major psychiatric illness.
- •Patients receiving benzodiazepines and narcotics.
- •Patients with compromised renal.
- •Patients receiving medications highly bound to plasma proteins eg. Warfarin.
- •Pregnant or lactating women.
- •Fulminant hepatic failure.
Arms & Interventions
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.
Intervention: Lactulose (Drug)
Polyeyhylene Glychol
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)
Intervention: Polyethylene Glycol (Drug)
Outcomes
Primary Outcomes
1 or more in HE grade improvement at 24 hours
Time Frame: 24 hours
HE grade improvement at 24 hours
Secondary Outcomes
- Overall length of stay(2 weeks)
- Time to HE resolution(2 weeks)
Investigators
Sherief Abd-Elsalam
Clinical Ass Prof. Hepatology and Gastroenterology
Tanta University