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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01923376
Other study ID # 401550
Secondary ID
Status Withdrawn
Phase N/A
First received July 25, 2013
Last updated May 9, 2015
Start date February 2013
Est. completion date February 2014

Study information

Verified date May 2015
Source New York Methodist Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
United States New York Methodist Hospital Brooklyn New York

Sponsors (1)

Lead Sponsor Collaborator
New York Methodist Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of cognition 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 24 hours from the time of enrollment No
Secondary Duration of hospital stay To determine if treatment with polyethylene glycol compared to lactulose will reduce the duration of hospital stay From time of admission to time of discharge an approximate length of seven days No
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