Contact information
Type
Scientific
Primary contact
Dr Laurence Solomon
ORCID ID
Contact details
Renal Unit
Royal Preston Hospital
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
laurie.solomon@lthtr.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
This is an observational study based on routine clinical practice, which does not require ethics approval.
Study design
Open-label observational study with retrospective comparator groups
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
1. Time to first use thrombolysis for poor catheter flows
2. Time to first bacteremia
Secondary outcome measures
1. Incidence of gram-negative, gram-positive and staphylococcus aureus bacteraemia per 1000 catheter-days
2. Catheter survival after censoring for elective removal
Overall trial start date
01/03/2009
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
All adult haemodialysis patients requiring an internal jugular intravascular catheter for haemodialysis dialysing at single Haemodialysis Centre in NorthWest England.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
106
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/03/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Renal Unit
Preston
PR2 9HT
United Kingdom
Sponsor information
Organisation
Lancashire Teaching Hospitals NHS trust (UK)
Sponsor details
Sharoe Green Lane
Preston
PR2 3LX
United Kingdom
laurie.solomon@lthtr.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Lancashire Teaching Hospitals NHS trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/21916999
Publication citations
-
Results
Solomon LR, Cheesbrough JS, Bhargava R, Mitsides N, Heap M, Green G, Diggle P, Observational study of need for thrombolytic therapy and incidence of bacteremia using taurolidine-citrate-heparin, taurolidine-citrate and heparin catheter locks in patients treated with hemodialysis., Semin Dial, 25, 2, 233-238, doi: 10.1111/j.1525-139X.2011.00951.x.