Condition category
Digestive System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
15/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J G Freeman

ORCID ID

Contact details

Southern Derbyshire Acute Hospitals NHS Trust
Gastroenterology & Liver Unit
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077132415

Study information

Scientific title

Prospective study of Molecular Adsorbents Recirculating System (MARS) therapy in chronic stable hepatic dysfunction

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2004

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with stable alcoholic liver disease who are currently abstinent from alcohol.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/2004

Recruitment end date

01/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Southern Derbyshire Acute Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes