Study of the effects of gentamicin locking on bacteraemia rates and function of tunnelled haemodialysis catheters
| ISRCTN | ISRCTN15520615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15520615 |
| Secondary identifying numbers | N0077102812 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 17/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr C W McIntyre
Scientific
Scientific
Southern Derbyshire Acute Hospitals NHS Trust
Department of Nephrology
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
| Phone | +44 (0)1332 340131 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Whether use of gentamicin locking of dialysis catheters can influence bacteraemia rates without compromising catheter function. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Haemodialysis |
| Intervention | Patients will be recruited at the time of catheter insertion and randomised to one of two arms. Conventional practice (as defined by use of heparin locking with 5000 u/ml) and locking the catheter with 5 mg/ml of gentamicin in conjunction with heparin. |
| Intervention type | Other |
| Primary outcome measure | We will collect data on a variety of endpoints. Primary end point will be clinical infection rates. Data will also be collected on patency and thrombotic failure of catheters augmented with the data set relating to catheter function and dialysis adequacy that will be captured by the central server. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2002 |
| Completion date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | The aim would be to recruit a total of 30-40 patients, who would be studied for 6-12 months. |
| Key inclusion criteria | Chronic haemodialysis patients |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 01/04/2003 |
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 (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2004 | Yes | No |
