Evaluation of Suprapubic Noble Metal Alloy BIP Foley Catheter in the Prevention of Catheter-associated Urinary Tract Infections in Spinal Cord Injured Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Incidence of CAUTI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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))
结局指标
主要结局
Incidence of CAUTI
时间窗: ~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)
次要结局
- Antibiotics, number of treatment days(~4 year observational time, the study has an open end and may be prolonged)
- Incidence of spontaneous urinary and blood cultures and CRP blood(~4 year observational time, the study has an open end and may be prolonged)
- Antibiotics type(~4 year observational time, the study has an open end and may be prolonged)
- Incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremia(~4 year observational time, the study has an open end and may be prolonged)
- Incidence and typ of advese events(~4 year observational time, the study has an open end and may be prolonged)
- 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)
- Antibiotics dose(~4 year observational time, the study has an open end and may be prolonged)