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

Cirrhosis Clinical Trial

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

Status Withdrawn

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.

Clinical Trial 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 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

• NCT number: NCT01923376
• Study type: Interventional
• Source: New York Methodist Hospital
• Status: Withdrawn
• Phase: N/A
• Start date: February 2013
• Completion date: February 2014