Condition category
Infections and Infestations
Date applied
12/10/2009
Date assigned
08/12/2009
Last edited
18/07/2016
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

Mr Amar Mohee

ORCID ID

Contact details

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

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20 ml of blood will be withdrawn from the cannula at the following time-points: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 measures

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

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

http://www.leedsteachinghospitals.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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