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

NCT01283152 | Completed Results DMC

• 1 other identifier: 072010-121
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy; Cirrhosis; Portosystemic Encephalopathy; PSE

Keywords

Hepatic Encephalopathy; HE; Cirrhosis; PSE; Portosystemic Encephalopathy; Hepatic coma; AMS; Altered mental status; Complications of cirrhosis; Chronic liver disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Hospital Duration/Length of Stay

  From time of admission to time of discharge or death

Study Arms (2)

Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)

ACTIVE COMPARATOR

Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)

Lactulose

OTHER

Per standard of care

Drug: Lactulose

Interventions

Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) DRUG

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

Also known as: GoLYTELY® or Miralax®

Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)

Lactulose DRUG

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

Lactulose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

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

Dallas, Texas, 75235, United States

Location

Related 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. No abstract available.

  PMID: 25244573 BACKGROUND

• 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.

  PMID: 25243839 RESULT

Related Links

• PubMed link to abstract

MeSH Terms

Conditions

Hepatic Encephalopathy; Fibrosis

Interventions

Golytely; polyethylene glycol 3350; Lactulose

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Results Point of Contact

• Title: Robert S. Rahimi, M.D., M.S.C.R. Assistant Professor, Department of Medicine
• Organization: Baylor University Medical Center

Robert.Rahimi@Baylorhealth.edu

214-820-8500

Study Officials

• Robert S Rahimi, MD, MSCR

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSCR

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 25, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 11, 2014
• Results First Posted: December 11, 2014

Record last verified: 2014-12

Locations

US (1)