Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.) (HELP)

The purpose of this study is to evaluate whether the use of polyethylene glycol is superior and more safe in treating hepatic encephalopathy compared to lactulose and also to determine if treatment with polyethylene glycol will reduce the duration of hospital stay.

Study Overview

• Status: Withdrawn
• Conditions: Hepatic Encephalopathy; Cirrhosis; Altered Mental Status; HE; AMS
• Intervention / Treatment: Drug: Lactulose; Drug: Polyethylene Glycol 3350

Detailed Description

Hepatic encephalopathy is the occurrence altered level of consciousness as a result of cirrhosis and liver failure. Main treatment goal for hepatic encephalopathy is to eliminate the precipitating factor and to decrease circulating ammonia level. Current standard for treating HE is treatment with Lactulose. Lactulose are metabolized by colonic bacteria to byproducts which cause catharsis and reduces pH, thereby inhibiting ammonia absorption. However, there is limited evidence available to demonstrate the efficacy. Studies on animal model have suggested that polyethylene glycol 3350-electrolyte solution (GOLYTELY) is effective in clearing gut bacteria and reducing the ammoniagenesis in colon. Recently published study by Robert Rahimi, University of Texas Southwestern Medical Center found that polyethylene glycol is more effective in improving HE over the first 24 hours compared to lactulose and also may reduce duration of hospital stay.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 - 80
• Male and female of all races and ethnicities
• Cirrhosis of any cause
• Any grade of hepatic encephalopathy (1-4)
• Representatives have to be 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 subject's behalf

Exclusion Criteria:

• Acute liver failure
• Prisoners
• Structural brain lesions (as indicated by CT and confirmed by neurological exam)
• Other causes of altered mental status
• Previous use of rifaximin or neomycin within last 7 days
• Pregnancy
• Serum Na <125 MEq/liter
• Receiving more than 1 dose (30 cc) of lactulose prior to enrollment
• Uncontrolled infection with hemodynamic instability requiring vasopressors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lactulose; per standard of care	Drug: Lactulose; If randomized to this group, subjects will receive 10 - 30 grams of lactulose per standard of care; Other Names: Enulose, Duphalac, generlac, kristalose
Active Comparator: polyethylene glycol 3350 (Golytely)	Drug: Polyethylene Glycol 3350; If subject is randomized to this group, one time dose of one gallon polyethylene glycol 3350 will be given at the time of enrollment; Other Names: Miralax; Golytely

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of cognition	Subjects will be evaluated every 24hr from the time of enrollment to assess for improvement of cognition until back to baseline and/or grade 0 based on HESA scare	24 hours from the time of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospital stay	To determine if treatment with polyethylene glycol compared to lactulose will reduce the duration of hospital stay	From time of admission to time of discharge an approximate length of seven days

Collaborators and Investigators

• Sponsor: New York Presbyterian Brooklyn Methodist Hospital
• Investigators: Principal Investigator: Smruti R Mohanty, MD, New York Presbyterian Brooklyn Methodist Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: July 25, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (Estimate): August 15, 2013

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 9, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Fibrosis; Pathologic Processes; Liver Cirrhosis; Nervous System Diseases; Digestive System Diseases; Virus Diseases; Central Nervous System Diseases; Confusion; hepatic encephalopathy; cirrhosis; Liver Diseases; Encephalitis; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Delirium; Brain Diseases; Metabolic Diseases; Signs and Symptoms; Delirium, Dementia, Amnestic, Cognitive Disorders; Liver Failure; Neurobehavioral Manifestations; Hepatic Insufficiency; Central Nervous System Infections; HE; PSE; lactulose; hepatic coma; golytely; Brain Damage, Chronic; Neurotoxicity Syndromes; Brain Diseases, Metabolic; Central Nervous System Viral Diseases; Poisoning; Citric Acid
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Fibrosis; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Gastrointestinal Agents; Laxatives; Lactulose; Polyethylene glycol 3350
• Other Study ID Numbers: 401550