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

N/AWithdrawnNCT01923376

New York Presbyterian Brooklyn Methodist Hospital

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Hepatic Encephalopathy HE Cirrhosis Altered Mental Status AMS

Interventions

LactuloseDRUG

If randomized to this group, subjects will receive 10 - 30 grams of lactulose per standard of care

Polyethylene Glycol 3350DRUG

If subject is randomized to this group, one time dose of one gallon polyethylene glycol 3350 will be given at the time of enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

New York Methodist Hospital

Brooklyn, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 24 hours from the time of enrollment

Secondary Outcomes

Duration of hospital stay

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

Data from ClinicalTrials.gov

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