NCT01923376

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: New York Presbyterian Brooklyn Methodist Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Lactulose	If randomized to this group, subjects will receive 10 - 30 grams of lactulose per standard of care
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

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-08-15
• Last updated: 2015-05-12

Locations

1 site across 1 country: United States