Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.
NCT ID: NCT01283152
Last Updated: 2014-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2011-01-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
Lactulose
Per standard of care
Lactulose
If randomized to this arm, subjects will receive 10-30 grams per standard of care
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Robert Rahimi, MD, MSCR
MD, MSCR
Principal Investigators
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Robert S Rahimi, MD, MSCR
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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University of Texas Southwestern Medical Center and Parkland Memorial Health and Hospital System
Dallas, Texas, United States
Countries
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References
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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. No abstract available.
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/jamainternmed.2014.4746.
Related Links
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PubMed link to abstract
Other Identifiers
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072010-121
Identifier Type: -
Identifier Source: org_study_id