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
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
-
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.