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Completed

NCT Number: NCT01283152

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

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.

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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Cirrhosis Digestive System Diseases Fibrosis Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases PSE Pathologic Processes Pathological Conditions, Signs and Symptoms Portosystemic Encephalopathy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center and Parkland Memorial Health and Hospital System

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • <18 years old
  • Serum sodium <125 mEq/L
  • Receiving > 1 dose of lactulose prior to enrollment
  • Uncontrolled infection with hemodynamic instability requiring vasopressors

Treatment and study plan

Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)

Drug

If randomized to this arm, subjects will receive a 1 time dose of 1 gallon

Other names: GoLYTELY® or Miralax®

Lactulose

Drug

If randomized to this arm, subjects will receive 10-30 grams per standard of care

Primary outcomes

  1. Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours

    Time frame: 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

  2. Change in HE Grade at 24 Hours

    Time frame: 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 outcomes

  1. Hospital Duration/Length of Stay

    Time frame: From time of admission to time of discharge or death

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Acronym: PSE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 25, 2011
Registry last updated
Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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