Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A one-year, prospective, observational, cohort, single centre study on the incidence, intensity, duration and identity of bacteraemia in patients undergoing transurethral resection of the prostate (TURP), extracorporeal shockwave lithotripsy (ESWL) and urinary catheter change
Acronym
Study hypothesis
Primary hypothesis:
Instrumentation during urological procedures does not cause bacteraemia.
Secondary hypothesis:
There is no link between infective endocarditis and preceding surgical instrumentation.
Ethics approval
Leeds Central Research Ethics Committee approval pending as of 13/10/2009
Study design
Prospective observational cohort single centre study
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
Bacteraemia
Intervention
The enrolled participants will provide a urine sample prior to the start of their procedure. They will then have an intravenous cannula inserted aseptically, preferably in their antecubital fossa. The cannula will be connected to a 3-way tap, with one output connected to a slow-drip to keep the cannula patent. The other output will be used to acquire blood for the study.
20 ml of blood will be withdrawn from the cannula at the following time-points:
1. 5 minutes pre-procedure
2. 2 minutes into the procedure
3. 5 minutes into the procedure
4. 10 minutes into the procedure
5. End of the procedure
6. 10 minutes after the end of the procedure
7. 30 minutes after the end of the procedure
8. 60 minutes after the end of the procedure
The blood thus acquired will be transferred into commercially available aerobic and anaerobic blood bottles. These samples will be processed in the laboratory by the chief investigator within a reasonable time frame (within 3 hours) and used for culture and polymerase chain reaction (PCR) methods to identify the bacteria both qualitatively and quantitatively.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Presence of bacteraemia, assessed at time of culture and PCR
Secondary outcome measures
Development of infective endocarditis. A year after obtaining the samples, participants will be contacted by phone or mail to see whether they have suffered an episode of infection in that year which required hospital admission. If that is the case, the hospital notes of the said patients will be obtained and data collected from the notes about the said episode of infection.
Overall trial start date
01/12/2009
Overall trial end date
01/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults (18 years onwards)
2. Both male and female (male only for the transurethral resection of the prostate [TURP] cohort)
3. Patient undergoing TURP, extracorporeal shock-wave lithotripsy and urinary catheter change at the Leeds Teaching Hospital NHS Trust
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
TURP: 200; ESWL: 250; Catheter-Change: 300
Participant exclusion criteria
1. Age less than 18 years
2. Not competent to consent for enrolment in the study
3. Signs and symptoms of ongoing infection (of any source) at presentation to the hospital
4. Use of systemic antibiotics within the 2 weeks of presentation to the hospital
5. Recent (within 2 weeks) instrumentation of the urological tract (not including urethral or suprapubic catheterisation)
6. Patient with poor veins, leading to difficult venous cannulation
Recruitment start date
01/12/2009
Recruitment end date
01/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Urology Department
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Leeds Teaching Hospitals NHS Trust (UK)
Sponsor details
Beckett St
Leeds
LS9 7TF
United Kingdom
+44 (0)113 243 3144
jon.cartledge@leedsth.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching 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
Basic results (scientific)
Publication list