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

• Status: Withdrawn
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York Methodist Hospital; New York Presbyterian Brooklyn Methodist Hospital
• Treatments: Lactulose; Polyethylene glycol 3350

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.