Bacteraemia post-urological instrumentation: endocarditis risk?

ISRCTN	ISRCTN89902973
DOI	https://doi.org/10.1186/ISRCTN89902973
Protocol serial number	N/A
Sponsor	Leeds Teaching Hospitals NHS Trust (UK)
Funder	Leeds Teaching Hospitals NHS Trust (UK)

Submission date: 12/10/2009
Registration date: 08/12/2009
Last edited: 18/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Amar Mohee
Scientific

Urology Department
Lincoln Wing
St James Hospital
Beckett St
Leeds
LS9 7TF
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective observational cohort single centre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Leeds Central Research Ethics Committee approval pending as of 13/10/2009
Health condition(s) or problem(s) studied	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 The other output will be used to acquire blood for the study. 20 ml of blood will be withdrawn from the cannula at the following time-points: 1. 5 minutes pre-procedure 2. 2 minutes into the procedure 3. 5 minutes into the procedure 4. 10 minutes into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
Primary outcome measure(s)	Presence of bacteraemia, assessed at time of culture and PCR
Key secondary outcome measure(s)	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.
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	750
Key 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
Key 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
Date of first enrolment	01/12/2009
Date of final enrolment	01/12/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Urology Department

Leeds
LS9 7TF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/07/2016: No publications found, verifying study status with principal investigator.