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

Hepatic Encephalopathy Clinical Trial

Official title:

Randomized Trial Comparing The Efficacy of PEG (Polyethylene Glycol) Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03100513
• Other study ID #: Hanan Soliman
• Status: Recruiting
• Phase: Phase 4
• First received: March 24, 2017
• Last updated: April 25, 2017
• Start date: March 11, 2017
• Est. completion date: December 2019

Study information

• Verified date: April 2017
• Source: Tanta University
• Contact: Sherief Abd-Elsalam, MD
• Phone: 00201095159522
• Email: Sheriefabdelsalam[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Adult Patients with Overt Hepatic Encephalopathy.

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.

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• 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
• Polyethylene Glycol
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).

Locations

Country	Name	City	State
Egypt	Tropical medicine dept.-Tanta university hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 or more in HE grade improvement at 24 hours	HE grade improvement at 24 hours	24 hours
Secondary	Time to HE resolution	Time to Hepatic encephalopathy resolution	2 weeks
Secondary	Overall length of stay	Overall length of stay	2 weeks