Cirrhosis Clinical Trial
— HELPOfficial title:
Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)
Verified date | May 2015 |
Source | New York Methodist Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New York Methodist Hospital | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
New York Methodist Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of cognition | Subjects will be evaluated every 24hr from the time of enrollment to assess for improvement of cognition until back to baseline and/or grade 0 based on HESA scare | 24 hours from the time of enrollment | No |
Secondary | Duration of hospital stay | To determine if treatment with polyethylene glycol compared to lactulose will reduce the duration of hospital stay | From time of admission to time of discharge an approximate length of seven days | No |
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