Role of antibiotic line locks in the prevention of tunnelled haemodialysis catheter infection: a double blind randomised controlled trial
| ISRCTN | ISRCTN93619348 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93619348 |
| Protocol serial number | N0280178863 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | Wirral Hospitals NHS Trust, NHS R&D Support Funding |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 18/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter McClelland
Scientific
Scientific
Arrowe Park Hospital
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
| Phone | +44 0151 678 5111 |
|---|---|
| jonathon.davies@whnt.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre double blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Will locking dialysis catheters with antibiotics immediately after placement into the patient reduce infection rate and prolong their life-span? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Injury, Occupational Diseases, Poisoning: Haemodialysis catheter infection |
| Intervention | 1G of vancomycin intraveously before catheter insertion. The catheter site will be inspected at each dialysis and cleaned with 10% aqueous povidone-iodine solution after each dialysis and each time the patient bathes. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Antibiotics |
| Primary outcome measure(s) |
Time in days to catheter-related infections. |
| Key secondary outcome measure(s) |
1. Haemoglobin concentration |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 80 |
| Key inclusion criteria | Patients aged 18 and above, stratified according to their diabetic status, requiring the insertion of a new tunnelled haemodyalisis catheter. |
| Key exclusion criteria | 1. Antibiotics for longer than 2 weeks 2. Pregnancy or planned pregnancy 3. Pregnancy 4. Allergy to vancomycin or gemtamicin 5. History of heparin induced thrombocytopaenia |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Arrowe Park Hospital
Wirral
CH49 5PE
United Kingdom
CH49 5PE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/01/2008 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
