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Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)

NCT01923376 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-05-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether the use of polyethylene glycol is superior and more safe in treating hepatic encephalopathy compared to lactulose and also to determine if treatment with polyethylene glycol will reduce the duration of hospital stay.

Conditions

  • Hepatic Encephalopathy
  • HE
  • Cirrhosis
  • Altered Mental Status
  • AMS

Interventions

DRUG

Lactulose

If randomized to this group, subjects will receive 10 - 30 grams of lactulose per standard of care

DRUG

Polyethylene Glycol 3350

If subject is randomized to this group, one time dose of one gallon polyethylene glycol 3350 will be given at the time of enrollment

Sponsors & Collaborators

  • New York Presbyterian Brooklyn Methodist Hospital

    lead OTHER

Principal Investigators

  • Smruti R Mohanty, MD · New York Presbyterian Brooklyn Methodist Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01923376 on ClinicalTrials.gov