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

This study is currently recruiting participants.
Verified August 2013 by New York Methodist Hospital
Sponsor:
Information provided by (Responsible Party):
Smruti R Mohanty, MD, New York Methodist Hospital
ClinicalTrials.gov Identifier:
NCT01923376
First received: July 25, 2013
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Hepatic Encephalopathy
HE
Cirrhosis
Altered Mental Status
AMS
Drug: Lactulose
Drug: Polyethylene Glycol 3350

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)

Resource links provided by NLM:


Further study details as provided by New York Methodist Hospital:

Primary Outcome Measures:
  • Improvement of cognition [ Time Frame: 24 hours from the time of enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: From time of admission to time of discharge an approximate length of seven days ] [ Designated as safety issue: No ]
    To determine if treatment with polyethylene glycol compared to lactulose will reduce the duration of hospital stay


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01923376

Contacts
Contact: Newaz Hossain, M.D. 917-402-5362 newaz.hossain@gmail.com
Contact: Yeshitila Mengesha, MD 347-446-4437 mengeshay@gmail.com

Locations
United States, New York
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Sub-Investigator: Newaz Hossain, MD         
Sub-Investigator: Yeshitila Mengesha, MD         
Sponsors and Collaborators
New York Methodist Hospital
Investigators
Principal Investigator: Smruti R Mohanty, MD New York Methodist Hospital
  More Information

No publications provided

Responsible Party: Smruti R Mohanty, MD, Chief of Gastroenterology, New York Methodist Hospital
ClinicalTrials.gov Identifier: NCT01923376     History of Changes
Other Study ID Numbers: 401550
Study First Received: July 25, 2013
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York Methodist Hospital:
Brain Diseases, Metabolic
Brain Diseases
hepatic encephalopathy
hepatic coma
HE
PSE
lactulose
golytely
cirrhosis
Hepatic Encephalopathy
Hepatic Insufficiency
Liver Cirrhosis
Fibrosis
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Liver Diseases
Digestive System 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

Additional relevant MeSH terms:
Brain Diseases, Metabolic
Brain Diseases
Hepatic Encephalopathy
Liver Cirrhosis
Fibrosis
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Mental Disorders
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System 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
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders
Lactulose
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014