N/A
Completed N=50
Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.
Hepatic Encephalopathy · Cirrhosis · Portosystemic Encephalopathy · PSE
Source: ClinicalTrials.gov NCT01283152 ↗
Enrolled (actual)
50
Serious AEs
16.0%
Results posted
Dec 2014
Primary outcomePrimary: Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours — 21; 13 participants
Summary
This study is being done to find out if the laxative polyethylene glycol (also known as GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). In this study, the investigators will evaluate if polyethylene glycol (GoLYTELY®) is more effective than lactulose on neurocognition (memory and thinking skills) and determine if it decreases the hospital stay.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours |
21; 13 | — |
| PRIMARY Change in HE Grade at 24 Hours |
10; 9; 9; 3; 1; 1 | — |
| SECONDARY Hospital Duration/Length of Stay |
4; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Ages 18-80
- Male and female subjects of all races and ethnicities including Spanish speaking subjects
- Cirrhosis of any cause
- Any grade of hepatic encephalopathy (1-4)
- A legally authorized representative has to be able and 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 subjects behalf
Exclusion Criteria
- Acute liver failure
- Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam)
- Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy)
- Previous use of rifaximin or neomycin in past 7 days
- Prisoners
- Pregnancy
- 1 dose of lactulose prior to enrollment
- Uncontrolled infection with hemodynamic instability requiring vasopressors
Data sourced from ClinicalTrials.gov (NCT01283152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.