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

Cirrhosis Clinical Trial

— HELP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01923376
• Other study ID #: 401550
• Status: Withdrawn
• Phase: N/A
• First received: July 25, 2013
• Last updated: May 9, 2015
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: New York Methodist Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Altered Mental Status
• AMS
• Brain Diseases
• Cirrhosis
• HE
• Hepatic Encephalopathy
• Mental Disorders

Intervention

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

Locations

Country	Name	City	State
United States	New York Methodist Hospital	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Methodist Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours from the time of enrollment	No
Secondary	Duration of hospital stay	To determine if treatment with polyethylene glycol compared to lactulose will reduce the duration of hospital stay	From time of admission to time of discharge an approximate length of seven days	No