Condition category
Urological and Genital Diseases
Date applied
04/07/2006
Date assigned
21/09/2006
Last edited
18/02/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Scott Morris

ORCID ID

Contact details

Renal Unit
3rd Floor Walton Building
Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

A new catheter-locking solution containing taurolodine and citrate has been shown to reduce catheter-related bacteraemia in small studies of mainly non-tunnelled catheters. We aim to test whether use of this solution will reduce the incidence of catheter-related bacteraemia in patients with tunnelled dialysis catheters.

Ethics approval

Medical Research Ethics Committee for Scotland A (reference: 06/MRE00/43), approval received 13/06/2006.

Study design

Interventional randomised double-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic Renal Failure requiring treatment with regular haemodialysis

Intervention

One group will be randomised to receive taurolidine-citrate catheter lock solution and the other heparin 5000 iu/ml catheter lock solution.

Added 18/02/2010: trial was stopped because objectives were no longer viable.

Intervention type

Drug

Phase

Not Specified

Drug names

Taurolidine, citrate and heparin

Primary outcome measures

Rates of catheter-related bacteraemia

Secondary outcome measures

1. Rates of catheter occlusion
2. Mortality rate
3. Exit-site infection rates
4. Epoietin requirements
5. Hospitalisation
6. Haemodialysis adequacy

Overall trial start date

01/10/2006

Overall trial end date

01/10/2008

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

1. Chronic renal failure requiring haemodialysis
2. Patients undergoing tunnelled haemodialysis catheter insertion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

164

Participant exclusion criteria

1. Aged under 16 years
2. Known intolerance to heparin or taurolidine-citrate
3. Patients receiving antibiotic treatment

Recruitment start date

01/10/2006

Recruitment end date

01/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Renal Unit
Glasgow
G4 0SF
United Kingdom

Sponsor information

Organisation

North Glasgow University NHS Division (UK)

Sponsor details

Greater Glasgow Health Board
c/o Dr Fiona Graham
East Research and Development Office
4th Floor Walton Building
Glasgow Royal Infirmary
Glasgow
G4 0SF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Glasgow Royal Infirmary Renal Unit Research Fund (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