A randomised controlled trial comparing taurolidine-citrate with heparin for locking tunnelled haemodialysis catheters
| ISRCTN | ISRCTN13630682 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13630682 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/07/2006
- Registration date
- 21/09/2006
- Last edited
- 18/02/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
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 Scott Morris
Scientific
Scientific
Renal Unit
3rd Floor Walton Building
Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom
Study information
| Study design | Interventional randomised double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Medical Research Ethics Committee for Scotland A (reference: 06/MRE00/43), approval received 13/06/2006. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Taurolidine, citrate and heparin |
| Primary outcome measure | 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 study start date | 01/10/2006 |
| Completion date | 01/10/2008 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 164 |
| Key inclusion criteria | 1. Chronic renal failure requiring haemodialysis 2. Patients undergoing tunnelled haemodialysis catheter insertion |
| Key exclusion criteria | 1. Aged under 16 years 2. Known intolerance to heparin or taurolidine-citrate 3. Patients receiving antibiotic treatment |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Renal Unit
Glasgow
G4 0SF
United Kingdom
G4 0SF
United Kingdom
Sponsor information
North Glasgow University NHS Division (UK)
Hospital/treatment centre
Hospital/treatment centre
Greater Glasgow Health Board
c/o Dr Fiona Graham
East Research and Development Office
4th Floor Walton Building
Glasgow Royal Infirmary
Glasgow
G4 0SF
Scotland
United Kingdom
"ROR" |
https://ror.org/05kdz4d87 |
|---|
Funders
Funder type
Hospital/treatment centre
Glasgow Royal Infirmary Renal Unit Research Fund (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 |
