Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.

Not Applicable

Completed

• Conditions: Portosystemic Encephalopathy; PSE; Hepatic Encephalopathy; Cirrhosis
• Interventions: Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®); Drug: Lactulose

• Registration Number: NCT01283152
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-12
• Results First Submitted: 2014-12-09
• Results First Submitted QC: 2014-12-09
• Last Update Submitted: 2014-12-09
• Results First Posted: 2014-12-11
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Ages 18-80
2. Male and female subjects of all races and ethnicities including Spanish speaking subjects
3. Cirrhosis of any cause
4. Any grade of hepatic encephalopathy (1-4)
5. 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

1. Acute liver failure
2. Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam)
3. Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy)
4. Previous use of rifaximin or neomycin in past 7 days
5. Prisoners
6. Pregnancy
7. <18 years old
8. Serum sodium <125 mEq/L
9. Receiving > 1 dose of lactulose prior to enrollment
10. Uncontrolled infection with hemodynamic instability requiring vasopressors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)	Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)	-
Lactulose	Lactulose	Per standard of care

Primary Outcome Measures

Name	Time	Method
Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours	Baseline to 24 hours	Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited (HESA improvement by at least 1 grade). HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA
Change in HE Grade at 24 Hours	Baseline to 24 hours	Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited. HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA

Secondary Outcome Measures

Name	Time	Method
Hospital Duration/Length of Stay	From time of admission to time of discharge or death

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center and Parkland Memorial Health and Hospital System; 🇺🇸 Dallas, Texas, United States