Complications; Catheter, Urinary Infection or Inflammation
Conditions
Brief summary
This is a prospective, cross-over, randomized, controlled, partly blinded study evaluating safety and performance of noble metal alloy urinary Catheters (BIP Foley, Bactiguard AB) of both latex and silicone. The included patients are permanently catheterized spinal cord injured patients at the Spinalis clinic at Rehab station in Stockholm, Sweden. Primary Outcome Measures: • The primary objective is to evaluate the efficacy of long term suprapubic use of BIP Foley catheters, compared to the use of standard catheters for the same time period, on re-current symptomatic catheter associated urinary tract infection (CAUTIs). Secondary Outcome Measures: • to evaluate safety/performance of the catheter, i.e. antibiotic use, bacteriuria, bacteremia, urosepsis and ICU stay. Exploratory Outcome Measures: • assessment of levels of immunological markers in urine, urinary bacterial type and resistance pattern, catheter comfort, stability of the coating, and bacterial biofilm on the catheter surface after use.
Interventions
DEVICEBIP Foley (latex) or BIP Foley -silicone
DEVICEStandard catheter
Sponsors
Rehab Station Stockholm
Bactiguard AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years) * Patients with permanent suprapubic urethral catheter (Foley catheter) of latex or silicone * At least 3 documented CAUTI infections during last year * Spinal Cord Injured, changing catheters at Rehab Station every 10 weeks (+/- 2 weeks)
Exclusion criteria
* Children (˂18 years) * Participating in other clinical trial(s) with exposure/treatment that could affect the outcome of the present study * Stones (calculi) in the urinary tract (these patients can be included after the stones have been removed) * Patients on antibiotic treatment (these patients can be included after the treatment is completed (+10 days of expectance))
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CAUTI | ~4 year observational time, the study has an open end and may be prolonged | The frequency of CAUTI will be recorded and compared between the use of standard urinary catheter and BIP Foley (with noble metal coating) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare ease of use of catheter by the nurse. Satisfaction assessed by ticking easy or not easy after each catheter exchange. | ~4 year observational time, the study has an open end and may be prolonged | The coated and uncoated catheters will be compared with regards to number of easy catheterization. |
| Incidence and typ of advese events | ~4 year observational time, the study has an open end and may be prolonged | To assess and compare the frequency and type of adverse events and catheter related adverse events in the two arms |
| Antibiotics type | ~4 year observational time, the study has an open end and may be prolonged | To assess and compare any differences of type of antibiotics used for CAUTI in the two arms. |
| Antibiotics dose | ~4 year observational time, the study has an open end and may be prolonged | To assess and compare any differences of antibiotic dose used for CAUTI in the two arms. |
| Antibiotics, number of treatment days | ~4 year observational time, the study has an open end and may be prolonged | To assess and compare any differences of number of treatment days of antibiotics used for CAUTI in the two arms. |
| Incidence of spontaneous urinary and blood cultures and CRP blood | ~4 year observational time, the study has an open end and may be prolonged | To asess and compare the spontaneous urinary and blood cultures and CRP blood in the two arms |
| Incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremia | ~4 year observational time, the study has an open end and may be prolonged | To asess and compare the incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremiain the two arms |
Other
| Measure | Time frame | Description |
|---|---|---|
| To assess the comfort of BIP Foley Catheters. Comfort is measured by a questionnaire filled in by the patients. | ~4 year observational time, the study has an open end and may be prolonged | The outcome of the questionnaire will be compared between the groups (standard versus coated catheter). The questions assess urine smell, appearance of the urine (i.e. colour), discomfort caused by the catheter, catheter blockage, discomfort at insertion/removal, and will be rated in a three-scale (not at all, little, much). |
| To asess inflammatory markers in urine of the patients and compare their levels between the groups. | ~4 year observational time, the study has an open end and may be prolonged | Urine samples will be collected during the study visit, and will be analysed with regards to inflammatory markers. Inflammatory levels (e.g. cytokines IL-8 and microparticles) will be determined, and compared between the groups. |
| To assess bacterial resistance pattern. | ~4 year observational time, the study has an open end and may be prolonged | The resistance pattern of present urinary bacteria in the two groups will be compared in urine samples collected at each study visit. |
| To assess and compare biofilm amount on the catheter surface. | ~4 year observational time, the study has an open end and may be prolonged | Biofilm amount on the catheter surface of uncoated and coated catheters will be assessed and compared by using SEM. Amounts will be given as % biofilm covering the surface area. |
| To assess the stability of the coating during long term use, by measurement of the (i.e. Ag, Au and Pd) concentration in urine and in blood and on used catheters, | ~4 year observational time, the study has an open end and may be prolonged | Urine and blood samples as well as used BIP Foley catheters, will be collected during the study visit, and the samples will be analysed with regards to metal concentrations (Ag, Au, and Pd). |
| To assess bacterial type | ~4 year observational time, the study has an open end and may be prolonged | The occurancy of bacterial strains in the two groups will be compared in urine samples collected at each study visit. |
Countries
Sweden
Outcome results
None listed