Bacteraemia post-urological instrumentation: endocarditis risk?

ISRCTN	ISRCTN89902973
DOI	https://doi.org/10.1186/ISRCTN89902973
Secondary identifying numbers	N/A

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

Study design	Prospective observational cohort single centre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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 The other output will be used to acquire blood for the study. 20 ml of blood will be withdrawn from the cannula at the following time-points: 1. 5 minutes pre-procedure 2. 2 minutes into the procedure 3. 5 minutes into the procedure 4. 10 minutes into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	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 study start date	01/12/2009
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	TURP: 200; ESWL: 250; Catheter-Change: 300
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

England
United Kingdom

Study participating centre

Urology Department

Leeds
LS9 7TF
United Kingdom

Sponsor information

Leeds Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre

Beckett St
Leeds
LS9 7TF
England
United Kingdom

Phone	+44 (0)113 243 3144
Email	jon.cartledge@leedsth.nhs.uk
Website	http://www.leedsteachinghospitals.com/
"ROR"	https://ror.org/00v4dac24

Funders

Funder type

Government

Leeds Teaching Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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