Multicentric, Controlled, Randomized Clinical Trial to Assess the Efficacy and Cost-effectiveness of Urinary Catheters With Silver Alloy Coating Versus Conventional Catheters in Spinal Cord Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 489
- 试验地点
- 30
- 主要终点
- Incidence of catheter associated urinary tract infection
研究概览
简要总结
The purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections.
详细描述
Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce urinary tract infections; however, research evidence cannot be extrapolated to spinal cord injured patients.
The study is an open, randomized, multicentric, and parallel clinical trial with blinded assessment. The study includes spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants are on-line centrally randomized and allocated to one of the two interventions (Antiseptic Urinary Catheters or Conventional Catheters). Catheters are used for a maximum period of 30 days or removed earlier at the clinician criteria.
The main outcome is the incidence of urinary tract infections by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients.
The aim of this study is to assess whether silver alloy-coated silicone urinary catheters reduce urinary infections in spinal cord injured patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or female patients with traumatic or medical spinal cord injury
- •Age of 18 years or above
- •Patients who need an indwelling urinary catheter as a method of bladder drainage for at least 7 days.
- •Patients who are willing to participate in the study and give their written informed consent (If a patient is unable to give written consent because of physical or mental disability, an affirmation of consent will be taken in his presence from his relative or legal guardian).
排除标准
- •Patients who can benefit from other method of bladder drainage such as intermittent catheterization, suprapubic drainage, reflex voiding or use of an external collector.
- •Patients with urinary tract infection at the moment of inclusion
- •Current antibiotic use or use within 7 days prior to inclusion
- •Outpatients with sporadic medical examinations (less than one per month)
- •Known allergy to latex, silver salts or hydrogels.
- •Patients with surgical interventions in the urinary tract that may interfere, at the investigator criteria, with the study results.
- •Pregnant or breastfeeding woman.
结局指标
主要结局
Incidence of catheter associated urinary tract infection
时间窗: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Is considered that a patient suffer a urinary tract infection if they have at least one suggestive sign or symptom with no other recognized cause and a positive urine culture with no more than 2 species of microorganisms. An urinary tract infection is considered catheter associated if the specimen collection is performed at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first).
次要结局
- Bacteremic urinary tract infection(at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first))
- Asymptomatic urinary tract infection(at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first))