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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-11

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatic Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Lactulose

Intervention Type 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

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)

Group Type ACTIVE_COMPARATOR

Polyethylene Glycol

Intervention Type 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).

Interventions

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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

Intervention Type DRUG

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).

Intervention Type DRUG

Other Intervention Names

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Duphlac, lactulose

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No