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
Secondary identifying numbers N/A
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

Renal Unit
Royal Preston Hospital
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom

Email laurie.solomon@lthtr.nhs.uk

Study information

Study designOpen-label observational study with retrospective comparator groups
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Scientific titleEvaluating 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 objectivesTo 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) studiedTunnelled intravascular catheters for haemodialysis
InterventionInterdialytic 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 typeProcedure/Surgery
Primary outcome measure1. Time to first use thrombolysis for poor catheter flows
2. Time to first bacteremia
Secondary outcome measures1. Incidence of gram-negative, gram-positive and staphylococcus aureus bacteraemia per 1000 catheter-days
2. Catheter survival after censoring for elective removal
Overall study start date01/03/2009
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants106
Key inclusion criteriaAll adult haemodialysis patients requiring an internal jugular intravascular catheter for haemodialysis dialysing at single Haemodialysis Centre in NorthWest England.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/03/2009
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Renal Unit
Preston
PR2 9HT
United Kingdom

Sponsor information

Lancashire Teaching Hospitals NHS trust (UK)
Hospital/treatment centre

Sharoe Green Lane
Preston
PR2 3LX
England
United Kingdom

Email laurie.solomon@lthtr.nhs.uk
ROR logo "ROR" https://ror.org/02j7n9748

Funders

Funder type

Government

Lancashire Teaching Hospitals NHS trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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