Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/08/2014
Date assigned
29/08/2014
Last edited
19/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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, King’s, 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 measures

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

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

Results - basic reporting

Publication summary

2017 results in http://fg.bmj.com/content/early/2017/04/07/flgastro-2016-100792

Publication citations

Additional files

Editorial Notes

19/05/2017: Publication reference added. In addition, the following changes have been made to the record: 1. The recruitment dates have been updated from 01/08/2014 - 30/03/2015 to 12/08/2014 - 24/06/2015 2. The overall trial dates have been updated from 01/08/2014 - 30/03/2015 to 11/07/2013 - 09/09/2016 3. The trial participating centres and IPD sharing statement have been added.