PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy

Phase 4

• Conditions: Hepatic Encephalopathy
• Interventions: Drug: Lactulose; Drug: Polyethylene Glycol

• Registration Number: NCT03100513
• Lead Sponsor: Sherief Abd-Elsalam

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 Timeline

• Study Start: 2017-03-11
• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-03-28
• Status Verified: 2017-04
• Study First Posted: 2017-04-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adult Patients with Overt Hepatic Encephalopathy.

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Exclusion Criteria

1. Patients with active GIT bleeding.
2. Patients with history of bowel obstruction, perforation.
3. Patients with history of allergy to PEG.
4. Treatment with rifaximin or neomycin in the previous 7 days.
5. Patients with major psychiatric illness.
6. Patients receiving benzodiazepines and narcotics.
7. Patients with compromised renal.
8. Patients receiving medications highly bound to plasma proteins eg. Warfarin.
9. Pregnant or lactating women.
10. Fulminant hepatic failure.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactulose	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.
Polyeyhylene Glychol	Polyethylene Glycol	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)

Primary Outcome Measures

Name	Time	Method
1 or more in HE grade improvement at 24 hours	24 hours	HE grade improvement at 24 hours

Secondary Outcome Measures

Name	Time	Method
Time to HE resolution	2 weeks	Time to Hepatic encephalopathy resolution
Overall length of stay	2 weeks	Overall length of stay

Trial Locations

Locations (1)

Tropical medicine dept.-Tanta university hospital; 🇪🇬 Cairo, Egypt