Clinical trial NCT01923376: Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)
Official title: Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: New York Presbyterian Brooklyn Methodist Hospital
Sponsor class: OTHER
First posted: 2013-08-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improvement of cognition
timeFrame: 24 hours from the time of enrollment
Secondary outcomes:
measure: Duration of hospital stay
timeFrame: From time of admission to time of discharge an approximate length of seven days
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
Study officials:
affiliation: New York Presbyterian Brooklyn Methodist Hospital
name: Smruti R Mohanty, MD
role: PRINCIPAL_INVESTIGATOR
References: