Complications; Catheter, Urinary Infection or Inflammation Clinical Trial
— CDOCOfficial title:
Evaluation of Suprapubic Noble Metal Alloy BIP Foley Catheter in the Prevention of Catheter-associated Urinary Tract Infections in Spinal Cord Injured Patients
| Verified date | January 2021 |
| Source | Bactiguard AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | March 9, 2020 |
| Est. primary completion date | March 9, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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)) |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Rehab Station Stockholm | Stockholm | Solna |
| Lead Sponsor | Collaborator |
|---|---|
| Bactiguard AB | Rehab Station Stockholm |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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, | 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). | ~4 year observational time, the study has an open end and may be prolonged | |
| Other | To assess the comfort of BIP Foley Catheters. Comfort is measured by a questionnaire filled in by the patients. | 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). | ~4 year observational time, the study has an open end and may be prolonged | |
| Other | To asess inflammatory markers in urine of the patients and compare their levels between the groups. | 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. | ~4 year observational time, the study has an open end and may be prolonged | |
| Other | To assess bacterial type | The occurancy of bacterial strains in the two groups will be compared in urine samples collected at each study visit. | ~4 year observational time, the study has an open end and may be prolonged | |
| Other | To assess bacterial resistance pattern. | The resistance pattern of present urinary bacteria in the two groups will be compared in urine samples collected at each study visit. | ~4 year observational time, the study has an open end and may be prolonged | |
| Other | To assess and compare biofilm amount on the catheter surface. | 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. | ~4 year observational time, the study has an open end and may be prolonged | |
| Primary | Incidence of CAUTI | The frequency of CAUTI will be recorded and compared between the use of standard urinary catheter and BIP Foley (with noble metal coating) | ~4 year observational time, the study has an open end and may be prolonged | |
| Secondary | Incidence and typ of advese events | To assess and compare the frequency and type of adverse events and catheter related adverse events in the two arms | ~4 year observational time, the study has an open end and may be prolonged | |
| Secondary | To compare ease of use of catheter by the nurse. Satisfaction assessed by ticking "easy" or "not easy" after each catheter exchange. | The coated and uncoated catheters will be compared with regards to number of easy catheterization. | ~4 year observational time, the study has an open end and may be prolonged | |
| Secondary | Antibiotics type | To assess and compare any differences of type of antibiotics used for CAUTI in the two arms. | ~4 year observational time, the study has an open end and may be prolonged | |
| Secondary | Antibiotics dose | To assess and compare any differences of antibiotic dose used for CAUTI in the two arms. | ~4 year observational time, the study has an open end and may be prolonged | |
| Secondary | Antibiotics, number of treatment days | To assess and compare any differences of number of treatment days of antibiotics used for CAUTI in the two arms. | ~4 year observational time, the study has an open end and may be prolonged | |
| Secondary | Incidence of spontaneous urinary and blood cultures and CRP blood | To asess and compare the spontaneous urinary and blood cultures and CRP blood in the two arms | ~4 year observational time, the study has an open end and may be prolonged | |
| Secondary | Incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremia | To asess and compare the incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremiain the two arms | ~4 year observational time, the study has an open end and may be prolonged |