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

Not Applicable

Withdrawn

• Conditions: Cirrhosis; AMS; Hepatic Encephalopathy; HE; Altered Mental Status
• Interventions: Drug: Lactulose; Drug: Polyethylene Glycol 3350

• Registration Number: NCT01923376
• Lead Sponsor: New York Presbyterian Brooklyn 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.

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-15
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-09
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactulose	Lactulose	per standard of care
polyethylene glycol 3350 (Golytely)	Polyethylene Glycol 3350	-

Primary Outcome Measures

Name	Time	Method
Improvement of cognition	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

Name	Time	Method
Duration of hospital stay	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

Trial Locations

Locations (1)

New York Methodist Hospital; 🇺🇸 Brooklyn, New York, United States