Condition category
Infections and Infestations
Date applied
07/06/2004
Date assigned
26/09/2005
Last edited
05/02/2013
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 Peter McClelland

ORCID ID

Contact details

Arrowe Park Hospital
Liverpool
CH49 5PE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

08/05

Study information

Scientific title

Acronym

Study hypothesis

The null hypothesis to be tested is that antibiotic line locks will not reduce the incidence of catheter related blood stream
infection compared with the standard practice of catheter filling with heparin alone.

Ethics approval

Not provided at time of registration

Study design

Randomised double blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Haemodialysis catheter related sepsis

Intervention

Control group will receive usual heparin line locks between dialysis sessions.
Intervention group will receive a line lock containing heparin, vancomycin and gentamicin.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The time in days from insertion of tunnelled haemodialysis catheter (THDC) to first catheter related infection (CRI). CRI will be diagnosed by a combination of clinical suspicion, raised temperature, blood tests (white
cell count and inflammatory markers) and the results of blood cultures from the tunnelled
haemodialysis catheter (THDC) and from a peripheral vein.

Secondary outcome measures

1. Mean haemoglobin concentration
2. Mean erythropoietin dose adjusted for body mass
3. Mean serum albumin concentration
4. Mean number of days in hospital per annum
5. Mean number of hospital admissions per annum

Overall trial start date

01/08/2004

Overall trial end date

01/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All patients requiring insertion of a tunnelled haemodialysis catheter (THDC) for haemodialysis.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Patients on prolonged courses of antibiotics (oral or parenteral) i.e. for greater than 2 weeks. (This may reduce the incidence of CRI and therefore confound the results).
2. Patients with a known allergy to vancomycin or gentamicin
3. Patients known to suffer from heparin induced thrombocytopenia
4. Patients who are pregnant or plan to become pregnant. (Vancomycin and gentamicin are potentially toxic to the fetus).
5. An inability to provide informed consent to participation in the study

Recruitment start date

01/08/2004

Recruitment end date

01/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Arrowe Park Hospital
Liverpool
CH49 5PE
United Kingdom

Sponsor information

Organisation

Wirral Hospitals NHS Trust (UK)

Sponsor details

Arrowe Park Hospital
Liverpool
CH49 5PE
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Funded within our department

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

Publication citations

Additional files

Editorial Notes