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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01923376
Recruitment Status : Withdrawn (Not enough staff to collect data)
First Posted : August 15, 2013
Last Update Posted : May 12, 2015
Information provided by (Responsible Party):
Smruti R Mohanty, MD, New York Methodist Hospital

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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy HE Cirrhosis Altered Mental Status AMS Drug: Lactulose Drug: Polyethylene Glycol 3350 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)
Study Start Date : February 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Improvement of cognition [ Time Frame: 24 hours from the time of enrollment ]
    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 :
  1. Duration of hospital stay [ Time Frame: From time of admission to time of discharge an approximate length of seven days ]
    To determine if treatment with polyethylene glycol compared to lactulose will reduce the duration of hospital stay

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01923376

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United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Sponsors and Collaborators
New York Methodist Hospital
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Principal Investigator: Smruti R Mohanty, MD New York Methodist Hospital

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Responsible Party: Smruti R Mohanty, MD, Chief of Gastroenterology, New York Methodist Hospital Identifier: NCT01923376     History of Changes
Other Study ID Numbers: 401550
First Posted: August 15, 2013    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by Smruti R Mohanty, MD, New York Methodist Hospital:
hepatic encephalopathy
hepatic coma
Hepatic Insufficiency
Liver Cirrhosis
Brain Damage, Chronic
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
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Additional relevant MeSH terms:
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Liver Cirrhosis
Hepatic Encephalopathy
Brain Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases
Polyethylene glycol 3350
Gastrointestinal Agents