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



Status:Completed
Conditions:Infectious Disease, Neurology, Psychiatric, Psychiatric, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 80
Updated:4/13/2015
Start Date:February 2013
End Date:February 2014
Contact:Newaz Hossain, M.D.
Email:newaz.hossain@gmail.com
Phone:917-402-5362

Use our guide to learn which trials are right for you!

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.

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.
We found this trial at
1
site
506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials