Prospective study of Molecular Adsorbents Recirculating System (MARS) therapy in chronic stable hepatic dysfunction
| ISRCTN | ISRCTN27485179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27485179 |
| Secondary identifying numbers | N0077132415 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 15/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J G Freeman
Scientific
Scientific
Southern Derbyshire Acute Hospitals NHS Trust
Gastroenterology & Liver Unit
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Prospective study of Molecular Adsorbents Recirculating System (MARS) therapy in chronic stable hepatic dysfunction |
| Study objectives | To test the hypothesis that Molecular Adsorbents Recirculating System (MARS) therapy could be used as a treatment for stable chronic alcoholic liver disease. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic alcoholic liver disease |
| Intervention | Patients with stable chronic alcoholic liver disease currently abstinent will be recruited from hepatology out-patient clinics. They will be randomised to a control non-treatment group or to MARS therapy. Those in the MARS group will be further randomised to group A or B. Those in group B will receive MARS every two weeks. The patients will be studied for 8 weeks. Vascular access would be by tunnelled cuffed right internal jugular dual lumen catheter inserted by a nephrologist under radiological screening. Hepatic encephalopathy, quality of life and symptom assessment will be sampled pre and post MARS treatments and in the non-MARS group at inclusion, 4 and 8 weeks. Portal pressure studies will be measured at the inclusion and the end of the study period. Systemic haemodynamics will be measured using a finometer. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Quality of life and symptom load 2. Level of hepatic encephalopathy and biochemical parameters 3. Level of portal hypertension and systemic haemodynamics |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2004 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients with stable alcoholic liver disease who are currently abstinent from alcohol. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Southern Derbyshire Acute Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
