Study of need for thrombolytic therapy and incidence of bacteremia using taurolidine-citrate-heparin, taurololidine-citrate and heparin catheter locks in patients treated with haemodialysis
| ISRCTN | ISRCTN07668752 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07668752 |
| Protocol serial number | N/A |
| Sponsor | Lancashire Teaching Hospitals NHS trust (UK) |
| Funder | Lancashire Teaching Hospitals NHS trust (UK) |
- Submission date
- 19/07/2010
- Registration date
- 27/04/2011
- Last edited
- 25/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Laurence Solomon
Scientific
Scientific
Renal Unit
Royal Preston Hospital
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
| laurie.solomon@lthtr.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Open-label observational study with retrospective comparator groups |
| Secondary study design | Cohort study |
| Scientific title | Evaluating the need for thrombolytic therapy and incidence of bacteremia using taurolidine-citrate-heparin, taurololidine-citrate and heparin catheter locks in patients treated with haemodialysis: An open-label, observational study with retrospective comparator groups |
| Study objectives | To determine whether addition of 500 units/ml of heparin to taurolidine-citrate catheter locks reduces the need for thrombolysis compared to taurolidine-citrate in haemodialysis patients using tunnelled intravascular catheters. |
| Ethics approval(s) | This is an observational study based on routine clinical practice, which does not require ethics approval. |
| Health condition(s) or problem(s) studied | Tunnelled intravascular catheters for haemodialysis |
| Intervention | Interdialytic locking with taurolidine-citrate-heparin (1.35% taurolidine, 4% citrate and 500 U/ml heparin) compared to taurolidine-citrate (1.35% taurolidine, 4% citrate) and heparin 5000U/ml. Total duration of follow up is10 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Time to first use thrombolysis for poor catheter flows |
| Key secondary outcome measure(s) |
1. Incidence of gram-negative, gram-positive and staphylococcus aureus bacteraemia per 1000 catheter-days |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 106 |
| Key inclusion criteria | All adult haemodialysis patients requiring an internal jugular intravascular catheter for haemodialysis dialysing at single Haemodialysis Centre in NorthWest England. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Renal Unit
Preston
PR2 9HT
United Kingdom
PR2 9HT
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 | 01/03/2012 | Yes | No |
