Randomized Controlled Open-label Trial Assessing the Efficacy of a Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 7
- 主要终点
- Number of participants recruited in each center during the trial
研究概览
简要总结
Pilot explanatory, randomized, open label, controlled trial. Critically ill patients which will demand placement of invasive devices for organ support (endotracheal tube, central venous catheter and urinary Foley catheter) will be randomized 1:1 to receive coated (Bactiguard®) or habitual (non-coated) devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to the intensive care unit which will require simultaneous insertion of all three devices (endotracheal tube, central venous catheter and urinary catheter) due to illness severity as defined by the attending physician.
排除标准
- •Patients admitted to the intensive care unit for more than 48 hours or admitted in the hospital for more than seven days
- •Presence of any of the invasive devices (endotracheal tube, central venous catheter or urinary catheters) before randomization and absence of the intention to exchange the devices;
- •Previous use of any type of coated devices;
- •Age < 18 years;
- •Known pregnancy
- •Known allergy to gold, silver and palladium;
- •Suspected or confirmed brain death;
- •Previously enrolled in the study
- •Newly added exclusion criteria in version 2.0:
- •Severe chronic pulmonary obstructive disease which may limit catheter site selection
- •Previous irradiation and/or thrombosis in site selected for catheter insertion
结局指标
主要结局
Number of participants recruited in each center during the trial
时间窗: Through study completion, an average of 1 year
Assess the recruitment rate
Number of participants admitted to the intensive care unit that requires simultaneous insertion of endotracheal tube, central venous catheter and urinary catheter
时间窗: Through study completion, an average of 1 year
Assess how many patients admitted to the intensive care unit will demand insertion of endotracheal tube, urinary catheter and central venous catheter after admission in all patients
Feasibility - Occurence of sepsis
时间窗: 28 days
Occurrence of sepsis after admission in patients that require all three devices to be inserted in all patients
次要结局
- Sepsis(28 days)
- Occurence of urinary catheter-related infection(28 days)
- Occurence of ventilator-associated pneumonia(28 days)
- Occurence of central venous catheter-related bloodstream infection(28 days)
- Rate of composite endpoint of ventilator-associated pneumonia and/or central venous catheter-related bloodstream infection and/or urinary catheter-related infection(28 days)
- Antibiotic-free days(28 days)
- Number of patients that die in Intensive Care Unit(Through intensive care unit stay, an average of 28 days)
- Number of patients that die during hospital stay(Through hospital stay, an average of 40 days)