Back to resultsHepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.) (HELP)
Primary Purpose
Hepatic Encephalopathy, HE, Cirrhosis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lactulose
Polyethylene Glycol 3350
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring hepatic encephalopathy, hepatic coma, HE, PSE, lactulose, golytely, cirrhosis, Hepatic Insufficiency, Liver Cirrhosis, Fibrosis, Brain Damage, Chronic, Delirium, Encephalitis, Neurotoxicity Syndromes, Liver Failure, 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, Citric Acid
Eligibility Criteria
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.
Sites / Locations
- New York Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Lactulose
polyethylene glycol 3350 (Golytely)
Arm Description
per standard of care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Duration of hospital stay
To determine if treatment with polyethylene glycol compared to lactulose will reduce the duration of hospital stay
Full Information
NCT ID
NCT01923376
First Posted
July 25, 2013
Last Updated
May 9, 2015
Sponsor
New York Presbyterian Brooklyn Methodist Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01923376
Brief Title
Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)
Acronym
HELP
Official Title
Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Not enough staff to collect data
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Presbyterian Brooklyn Methodist Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy, HE, Cirrhosis, Altered Mental Status, AMS
Keywords
hepatic encephalopathy, hepatic coma, HE, PSE, lactulose, golytely, cirrhosis, Hepatic Insufficiency, Liver Cirrhosis, Fibrosis, Brain Damage, Chronic, Delirium, Encephalitis, Neurotoxicity Syndromes, Liver Failure, 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, Citric Acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactulose
Arm Type
Other
Arm Description
per standard of care
Arm Title
polyethylene glycol 3350 (Golytely)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lactulose
Other Intervention Name(s)
Enulose, Duphalac, generlac, kristalose
Intervention Description
If randomized to this group, subjects will receive 10 - 30 grams of lactulose per standard of care
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycol 3350
Other Intervention Name(s)
Miralax, Golytely
Intervention Description
If subject is randomized to this group, one time dose of one gallon polyethylene glycol 3350 will be given at the time of enrollment
Primary Outcome Measure Information:
Title
Improvement of cognition
Description
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
Time Frame
24 hours from the time of enrollment
Secondary Outcome Measure Information:
Title
Duration of hospital stay
Description
To determine if treatment with polyethylene glycol compared to lactulose will reduce the duration of hospital stay
Time Frame
From time of admission to time of discharge an approximate length of seven days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Smruti R Mohanty, MD
Organizational Affiliation
New York Presbyterian Brooklyn Methodist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)
We'll reach out to this number within 24 hrs