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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Rahimi, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01283152
First received: January 24, 2011
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Hepatic Encephalopathy
Cirrhosis
Portosystemic Encephalopathy
PSE
 Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
Drug: Lactulose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Evaluating the Efficacy of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) in Patients With Hepatic Encephalopathy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Neurocognitive improvement [ Time Frame: At the 24 hour time point of when the subject was recruited (HESA improvement by at least 1 grade). 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital duration/length of stay [ Time Frame: From time of admission to time of discharge or death ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
Other Name: GoLYTELY® or Miralax®
Lactulose
Per standard of care
 Drug: Lactulose
If randomized to this arm, subjects will receive 10-30 grams per standard of care

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283152

Locations
United States, Texas
University of Texas Southwestern Medical Center and Parkland Memorial Health and Hospital System
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Robert S Rahimi, MD, MSCR University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Robert Rahimi, MD, MSCR, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01283152     History of Changes
Other Study ID Numbers: 072010-121
Study First Received: January 24, 2011
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Hepatic Encephalopathy
HE
Cirrhosis
PSE
Portosystemic Encephalopathy
 Hepatic coma
AMS
Altered mental status
Complications of cirrhosis
Chronic liver disease

Additional relevant MeSH terms:
Hepatic Encephalopathy
Liver Cirrhosis
Fibrosis
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Metabolic Diseases
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders
Lactulose
Citric Acid

ClinicalTrials.gov processed this record on May 22, 2013