Home Monitoring in Encephalopathy (The d-LIVER HoME trial) v1.0
Research type
Research Study
Full title
Home Monitoring in Encephalopathy (The d-LIVER HoME trial)
IRAS ID
156104
Contact name
James G Orr
Contact email
Sponsor organisation
Research and Development
Research summary
Hepatic Encephalopathy (HE) is a complication of advanced liver disease which can cause confusion or decreased conscious level. HE frequently results in emergency admission to hospital and is associated with severely impaired Health Related Quality of Life (HRQOL). The first-line treatment of HE is the laxative lactulose which works by increasing stool frequency resulting in a reduction in absorption of toxins produced by bacteria in the gut. However, in spite of this treatment, HE often worsens resulting in readmission to hospital. One potential contributing factor is that large doses of lactulose can be unpleasant for patients to take meaning that compliance with the drug may be poor, particularly when there appears to be no evidence of ongoing confusion.
This pilot evaluation aims to investigate the use of a home monitoring system to direct lactulose therapy in patients with a previous episode of overt HE. A simple cognitive test will be carried out by patients on a daily basis and stool frequency will be recorded using a tablet PC interface. These two parameters will be used to adjust lactulose dose where appropriate. In situations where there is evidence of increasing confusion which is not responding to treatment, intervention by a clinician will be initiated.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
14/NE/1114
Date of REC Opinion
29 Sep 2014
REC opinion
Further Information Favourable Opinion