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

Withdrawn before enrolling · Not applicable

Conditions studied: Hepatic Encephalopathy, HE, Cirrhosis, Altered Mental Status, AMS

In brief

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.

Key facts

Study ID

NCT01923376

Run by

New York Presbyterian Brooklyn Methodist Hospital

People needed

0

Starts

2013-02-01

Expected to finish

2014-02-01

Last updated by the study team

2015-05-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 - 80
• Male and female of all races and ethnicities
• Cirrhosis of any cause
• Any grade of hepatic encephalopathy (1-4)
• Representatives have to be willing to comply with all protocol procedures and to understand, sign and date an informed consent document and authorize access to protected health information on the subject's behalf

You may not qualify if…

• Acute liver failure
• Prisoners
• Structural brain lesions (as indicated by CT and confirmed by neurological exam)
• Other causes of altered mental status
• Previous use of rifaximin or neomycin within last 7 days
• Pregnancy
• Serum Na <125 MEq/liter
• Receiving more than 1 dose (30 cc) of lactulose prior to enrollment
• Uncontrolled infection with hemodynamic instability requiring vasopressors.

Where it is running

• New York Methodist Hospital — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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