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

Cirrhosis Clinical Trial

— PSE  

Official title:

Randomized Controlled Trial Evaluating the Efficacy of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) in Patients With Hepatic Encephalopathy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283152
• Other study ID #: 072010-121
• Status: Completed
• Phase: N/A
• First received: January 24, 2011
• Last updated: December 9, 2014
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2014
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Hepatic Encephalopathy
• Portosystemic Encephalopathy
• PSE

Intervention

Drug:
• Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
• Lactulose
If randomized to this arm, subjects will receive 10-30 grams per standard of care

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center and Parkland Memorial Health and Hospital System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Doran AE, Shah NL. Polyethylene glycol for hepatic encephalopathy: a new solution to purge an old problem? JAMA Intern Med. 2014 Nov;174(11):1734-5. doi: 10.1001/jamainternmed.2014.3501. — View Citation

Rahimi RS, Singal AG, Cuthbert JA, Rockey DC. Lactulose vs polyethylene glycol 3350--electrolyte solution for treatment of overt hepatic encephalopathy: the HELP randomized clinical trial. JAMA Intern Med. 2014 Nov;174(11):1727-33. doi: 10.1001/jamaintern — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With an Improvement of 1 or More in HE Grade at 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	Baseline to 24 hours	No
Primary	Change in HE Grade at 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	Baseline to 24 hours	No
Secondary	Hospital Duration/Length of Stay		From time of admission to time of discharge or death	No

External Links

•   Invited Commentary link
•   PubMed link to abstract