Plain English Summary
Background and study aims
Hepatic encephalopathy (HE) is a nervous system-related mental disorder for which symptoms include level of consciousness, slowing down of thoughts and movements, deterioration of mental status, confusion, and, in severe forms, coma. HE is a common complication of chronic liver cirrhosis caused by abnormal levels of toxins that accumulate in the blood, which are normally excreted in a healthy liver. We are carrying out a clinical study to understand the effect of a drug called rifaximin in treating patients with HE and how rifaximin is used in the management of HE in routine UK clinical practice.
Who can participate?
Patients who have been diagnosed with HE and are not taking rifaximin and patients on rifaximin for at least 12 months before the start of the study.
What does the study involve?
Details of all recorded inpatient (including critical care) and A&E episodes will be obtained for all patients, for the full 12-month periods before and after starting on rifaximin, even if rifaximin was discontinued prior to 12 months.
What are the possible benefits and risks of participating?
There is no additional risk to patients from taking part in this study since it only involves a retrospective review by a researcher of their medical records and electronic hospital admissions data.
Where is the study run from?
The study is run from tsecondary/tertiary care centres in the follwoing areas of the UK: Belfast, Bristol, Cambridge, Dundee, Durham, Edinburgh, Glasgow, Kings, Liverpool, Newcastle, Nottingham, Portsmouth, Royal Free, Southampton, Truro.
When is the study starting and how long is it expected to run for?
July 2013 to September 2016
Who is funding the study?
Norgine Ltd, UK (UK)
Who is the main contact?
1. Mr Robert Dew (public)
RobertDew@phassociates.com
2. Dr Sharmila Kar (scientific)
Skar@norgine.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mark Hudson
ORCID ID
Contact details
Freeman Hospital
Freeman Road
High Heaton Newcastle upon Tyne
Newcastle
NE7 7DN
United Kingdom
+44(0)191 233 6161
Mark.Hudson@nuth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZZ2013UK01
Study information
Scientific title
The impact of rifaximin on the NHS hospital resource use associated with the management of patients with hepatic encephalopathy (HE): a retrospective observational study
Acronym
IMPRESS
Study hypothesis
Clinical trial data have demonstrated the potential of rifaximin to reduce overt hepatic encephalopathy (HE) episodes and hospitalisations. There is therefore a need by physicians, commissioners and other healthcare professionals caring for people with HE to understand the impact of management with rifaximin on NHS resource use in real world clinical practice. Currently available data is from evaluations undertaken in single UK centres. The study also aims to describe the characteristics of patients currently being managed with rifaximin and the associated patient pathways. It is hoped that these data will provide valuable information for physicians and commissioners to assist decision making and facilitate effective service provision and patient management in the NHS both acutely and long-term.
Ethics approval
West of Scotland, REC 3, 20/06/2014, ref. 14/WS/1017
Study design
Non-interventional multi-centre retrospective observational research study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Hepatic encephalopathy
Intervention
This study will involve a review of the secondary/tertiary care medical records and electronic hospital admissions data for patients with hepatic encephalopathy who have received rifaximin as part of normal clinical practice. Patients initiated on rifaximin will be identified by members of the routine care team from hospital pharmacy databases with 6 months pre- vs post-initiation of rifaximin (liver specific). Data is collected from medical records and will be recorded and collected for the period of 12 months pre- and post-initiation of rifaximin.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Data collection for the 6 months pre- vs post-initiation of rifaximin (liver-specific), including number of hospital bed days per patient.
Secondary outcome measures
1. Comparison of resource use: 6 months pre- vs post-initiation of rifaximin (liver specific and all cause) mainly evaluating hospitalisation (and re-hospitalisation) rates and hospital length of stay including ITU/HDU admissions
2. Patients' demographics and disease-related characteristics
3. Patient pathway
4. Adverse drug reactions to rifaximin
Overall trial start date
11/07/2013
Overall trial end date
09/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with a clinical diagnosis of hepatic encephalopathy
2. Hepatic encephalopathy diagnosed prior to initiation of rifaximin
3. Patients initiated on rifaximin for hepatic encephalopathy at least 12 months prior to the date of data collection
4. Both female and male, no restriction of age
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
250-300 patients
Participant exclusion criteria
1. Patients receiving rifaximin where subsequent clinical diagnosis excludes hepatic encephalopathy
2. Patients initiated on rifaximin at hospitals not taking part in the study
3. Patients for whom hospital records are unavailable
Recruitment start date
12/08/2014
Recruitment end date
24/06/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Freeman Hospital
Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom
Trial participating centre
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
Trial participating centre
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Trial participating centre
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
Trial participating centre
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
Trial participating centre
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Trial participating centre
Royal Cornwall Hospital
Penventinnie Lane
Truro
TR1 3LQ
United Kingdom
Trial participating centre
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Trial participating centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Trial participating centre
Southmead Hospital
Southmead Road
Bristol
BS10 5NB
United Kingdom
Trial participating centre
Ninewells Hospital
Ninewells Avenue
Dundee
DD2 1UB
United Kingdom
Trial participating centre
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Trial participating centre
University Hospital of North Durham
North Road
Durham
DH1 5TW
United Kingdom
Sponsor information
Organisation
Norgine Ltd (UK)
Sponsor details
c/o Dr Sharmila Kar
Medical Director UK & IE
Norgine Ltd
Norgine House
Widewater Place
Moorhall Road
Uxbridge
London
UB9 6NS
United Kingdom
+44(0)1895 826 600
skar@norgine.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Norgine Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
IPD Sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
01/04/2017
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 results in http://fg.bmj.com/content/early/2017/04/07/flgastro-2016-100792