Condition category
Infections and Infestations
Date applied
09/08/2009
Date assigned
18/09/2009
Last edited
28/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
+44 (0)1772 522750
laurie.solomon@lthtr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Taurolidine-citrate catheter locks for the prevention of bacteraemia in patients using tunnelled intravascular catheters for haemodialysis: a randomised double-blind controlled trial

Acronym

Study hypothesis

The primary aim of this study is to evaluate the feasibility, efficacy and cost-effectiveness of taurolidine line locks in the prevention of bacteraemia in haemodialysis patients using tunnelled lines starting at the time of line insertion and whether use of taurolidine from the time of line insertion is associated with an increased need for thrombolytic therapy.

Ethics approval

Cumbria and Lancashire B Research Ethics committee approved on the 4th July 2006 (ref: 06/Q1309/30)

Study design

Randomised double-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Catheter-related bacteraemia

Intervention

Patients will randomised to receive either taurolidine-citrate or standard heparin (5000 IU/ml) line locks at the time of catheter insertion and after every dialysis until an end-point of the trial. Taurolidine will be supplied as 1.35% taurolidine and 4% citrate (TauroLock™, Tauropharm AG). Heparin will supplied as heparin sodium, Ph Eur (porcine) at 5000 IU/L with 1% benzylic acid as preservative (Braun AG). This trial will be completed six months after the recruitment of the last participant.

Intervention type

Drug

Phase

Not Applicable

Drug names

Taurolidine-citrate, heparin

Primary outcome measures

1. 'Intention to treat' analysis of symptomatic and asymptomatic bacteraemic episodes. A bacteraemic episode will be defined by a single positive blood culture. Symptoms will be judged clinically on the basis of fever or rigors associated with dialysis. Measured by a positive blood culture at the time when the patient has relevant symptoms
2. A comparison of the unassisted line patency rate between the two treatment groups. This will be based on the need for thrombolytic therapy or radiological intervention. Detected by a requirement to use of thrombolytic therapy and the date when this happened.

Secondary outcome measures

1. The type of bacterium, outcome of treatment with antibiotics and relapse rate in those patients with proven infection
2. C-reactive protein concentrations
3. Haemoglobin concentrations, measured monthly
4. Erythropoietin requirement, recorded every two weeks
5. Blood flows, recorded every two weeks
6. Electron microscopy of removed lines to look for Biofilm

Overall trial start date

01/11/2006

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (aged greater than 18 years), either sex
2. Requirement for dialysis using a tunnelled dialysis line
3. Able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 patients per group (total: 100 patients)

Participant exclusion criteria

1. Children aged less than 18 years
2. Unable to give informed consent
3. Positive blood culture in previous seven days
4. Unstable bleeding diathesis or hypercoagulable state

Recruitment start date

01/11/2006

Recruitment end date

30/09/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Renal Unit
Preston
PR2 9HT
United Kingdom

Sponsor information

Organisation

Lancashire Teaching Hospitals NHS Foundation Trust (UK)

Sponsor details

Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
+44 (0)1772 716565
laurie.solomon@lthtr.nhs.uk

Sponsor type

Government

Website

http://www.lancsteachinghospitals.nhs.uk/

Funders

Funder type

Government

Funder name

Lancashire Teaching Hospitals NHS Foundation Trust (UK) - internal funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Central Manchester University Hospitals NHS Foundation Trust (UK) - internal funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal Liverpool Hospital NHS Trust (UK) - internal funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

North West Kidney Research Association (UK) - small grant from the Preston Branch

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Liverpool Regional Dialysis Unit Fund (UK) - small grant

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20207458

Publication citations

  1. Results

    Solomon LR, Cheesbrough JS, Ebah L, Al-Sayed T, Heap M, Millband N, Waterhouse D, Mitra S, Curry A, Saxena R, Bhat R, Schulz M, Diggle P, A randomized double-blind controlled trial of taurolidine-citrate catheter locks for the prevention of bacteremia in patients treated with hemodialysis., Am. J. Kidney Dis., 2010, 55, 6, 1060-1068, doi: 10.1053/j.ajkd.2009.11.025.

Additional files

Editorial Notes