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

NCT ID: NCT01923376

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-02-28

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.

Conditions

Hepatic Encephalopathy; HE; Cirrhosis; Altered Mental Status; AMS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lactulose

per standard of care

Group Type: OTHER

Lactulose

Intervention Type: DRUG

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

polyethylene glycol 3350 (Golytely)

Group Type: ACTIVE_COMPARATOR

Polyethylene Glycol 3350

Intervention Type: DRUG

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

Interventions

Lactulose

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Enulose, Duphalac, generlac, kristalose; Miralax; Golytely

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Presbyterian Brooklyn Methodist Hospital

OTHER

Sponsor Role: lead

Responsible Party

Smruti R Mohanty, MD

Chief of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Smruti R Mohanty, MD

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Brooklyn Methodist Hospital

Locations

New York Methodist Hospital

Brooklyn, New York, United States

Countries

United States

Other Identifiers

401550

Identifier Type: -

Identifier Source: org_study_id