To understand the impact of rifaximin on the NHS hospital resource use associated with the management of patients with hepatic encephalopathy (HE)
| ISRCTN | ISRCTN61977500 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61977500 |
| Secondary identifying numbers | ZZ2013UK01 |
- Submission date
- 12/08/2014
- Registration date
- 29/08/2014
- Last edited
- 19/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Freeman Hospital
Freeman Road
High Heaton Newcastle upon Tyne
Newcastle
NE7 7DN
United Kingdom
| Phone | +44(0)191 233 6161 |
|---|---|
| Mark.Hudson@nuth.nhs.uk |
Study information
| Study design | Non-interventional multi-centre retrospective observational research study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Study acronym | IMPRESS |
| Study objectives | 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(s) | West of Scotland, REC 3, 20/06/2014, ref. 14/WS/1017 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 11/07/2013 |
| Completion date | 09/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 250-300 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/08/2014 |
| Date of final enrolment | 24/06/2015 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
Study participating centres
Newcastle upon Tyne
NE7 7DN
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
Nottingham
NG7 2UH
United Kingdom
London
NW3 2QG
United Kingdom
Liverpool
L7 8XP
United Kingdom
London
SE5 9RS
United Kingdom
Truro
TR1 3LQ
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Southampton
SO16 6YD
United Kingdom
Bristol
BS10 5NB
United Kingdom
Dundee
DD2 1UB
United Kingdom
Belfast
BT12 6BA
United Kingdom
Durham
DH1 5TW
United Kingdom
Sponsor information
Industry
c/o Dr Sharmila Kar, Medical Director UK & IE
Norgine Ltd, Norgine House
Widewater Place
Moorhall Road
Uxbridge
London
UB9 6NS
United Kingdom
| Phone | +44(0)1895 826 600 |
|---|---|
| skar@norgine.com | |
"ROR" |
https://ror.org/046zgtw08 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/04/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
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.
