Clinical Trial: Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)
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 Summary: 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.
Sponsor: New York Methodist Hospital
Current Primary Outcome: Improvement of cognition [ Time Frame: 24 hours from the time of enrollment ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Duration of hospital stay [ Time Frame: From time of admission to time of discharge an approximate length of seven days ]
Original Secondary Outcome: Same as current
Information By: New York Methodist Hospital
Dates:
Date Received: July 25, 2013
Date Started: February 2013
Date Completion:
Last Updated: May 9, 2015
Last Verified: May 2015
