Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/12/2008
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 C W McIntyre

ORCID ID

Contact details

Southern Derbyshire Acute Hospitals NHS Trust
Department of Nephrology
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 340131

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077102812

Study information

Scientific title

Acronym

Study hypothesis

Whether use of gentamicin locking of dialysis catheters can influence bacteraemia rates without compromising catheter function.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Urological and Genital Diseases: Haemodialysis

Intervention

Patients will be recruited at the time of catheter insertion and randomised to one of two arms. Conventional practice (as defined by use of heparin locking with 5000 u/ml) and locking the catheter with 5 mg/ml of gentamicin in conjunction with heparin.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

We will collect data on a variety of endpoints. Primary end point will be clinical infection rates. Data will also be collected on patency and thrombotic failure of catheters augmented with the data set relating to catheter function and dialysis adequacy that will be captured by the central server.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2002

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Chronic haemodialysis patients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

The aim would be to recruit a total of 30-40 patients, who would be studied for 6-12 months.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2002

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Southern Derbyshire Acute 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

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15253736

Publication citations

  1. Results

    McIntyre CW, Hulme LJ, Taal M, Fluck RJ, Locking of tunneled hemodialysis catheters with gentamicin and heparin., Kidney Int., 2004, 66, 2, 801-805, doi: 10.1111/j.1523-1755.2004.00806.x.

Additional files

Editorial Notes