Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
18/04/2012
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
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
+44 0151 678 5111
jonathon.davies@whnt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0280178863

Study information

Scientific title

Acronym

Study hypothesis

Will locking dialysis catheters with antibiotics immediately after placement into the patient reduce infection rate and prolong their life-span?

Ethics approval

Not provided at time of registration

Study design

Single centre double blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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

Condition

Injury, Occupational Diseases, Poisoning: Haemodialysis catheter infection

Intervention

1G of vancomycin intraveously before catheter insertion. The catheter site will be inspected at each dialysis and cleaned with 10% aqueous povidone-iodine solution after each dialysis and each time the patient bathes.

Intervention type

Drug

Phase

Not Specified

Drug names

Antibiotics

Primary outcome measures

Time in days to catheter-related infections.

Secondary outcome measures

1. Haemoglobin concentration
2. Erythropoetin dose
3. Serum albumin concentration
4. Hospital admission rate
5. Mean length of hospital stay

Overall trial start date

01/06/2006

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 18 and above, stratified according to their diabetic status, requiring the insertion of a new tunnelled haemodyalisis catheter.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

1. Antibiotics for longer than 2 weeks
2. Pregnancy or planned pregnancy
3. Pregnancy
4. Allergy to vancomycin or gemtamicin
5. History of heparin induced thrombocytopaenia

Recruitment start date

01/06/2006

Recruitment end date

30/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Arrowe Park Hospital
Wirral
CH49 5PE
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Wirral Hospitals NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18271841

Publication citations

  1. Results

    Casey J, Davies J, Balshaw-Greer A, Taylor N, Crowe AV, McClelland P, Inserting tunnelled hemodialysis catheters using elective guidewire exchange from nontunnelled catheters: is there a greater risk of infection when compared with new-site replacement?, Hemodial Int, 2008, 12, 1, 52-54, doi: 10.1111/j.1542-4758.2008.00240.x.

Additional files

Editorial Notes