Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Number of days hospitalized in the medical intensive care unit (length-of-stay)
研究概览
简要总结
Investigators will conduct a pragmatic randomized trial to investigate the non-inferiority of restricted use of invasive arterial lines compared to standard arterial line use.
详细描述
Patients in the medical intensive care unit (MICU) often receive arterial lines as standard of care, however there are little data to support this practice. Investigators will randomly assign consecutive weeks to either current practice(control) or to a more conservative practice of not placing invasive arterial lines except for limited indication indications as defined below (intervention). Patients entering during an intervention week will be treated according to the intervention practice throughout their ICU stay. Likewise, patients entering during a control week will be treated according to current standard practice.
Permuted block randomization will be used to assure equal numbers of intervention and control weeks. All outcome measures will be obtained through EPIC data analytics and post-hospitalization phone calls. Weekly randomization codes will be generated by the study statisticians and delivered to MICU staff via sealed envelopes to be opened at the beginning of each week.
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
- None
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
- •All subjects admitted to the medical intensive care unit
- •Exclusion Criterion:
- •All subjects <18 years of age.
排除标准
- 未提供
结局指标
主要结局
Number of days hospitalized in the medical intensive care unit (length-of-stay)
时间窗: inpatient hospitalization (approximately 1 to 30 days)
Number of days hospitalized in the medical intensive care unit
次要结局
- Number of vasopressors used(Inpatient hospitalization (approximately 1 to 60 days))
- Number of days using vasopressor medicines (vasopressor-days)(inpatient hospitalization (approximately 1 to 30 days))
- Number of days subjects experiencing death within 28 days of medical intensive care unit while having received vasopressor medicines (28-day mortality while on vasopressors)(Inpatient or outpatient death within 1 to 28 days)
- Number of days subjects experiencing death within 28 days of medical intensive care unit from any cause (28-day all-cause mortality)(Inpatient or outpatient death within 1 to 28 days)
- Number of days hospitalized in a non- medical intensive care unit (Hospital length-of-stay)(inpatient hospitalization (approximately 1 to 30 days))
- Number of participants experiencing a bloodstream infection related to invasive arterial catheter use(inpatient hospitalization (approximately 1 to 30 days) and experiencing 0 to 1 bloodstream infections)
- Number of participants experiencing a vascular injury related to the invasive arterial catheter(inpatient hospitalization (approximately 1 to 30 days))
- Number of days subjects experiencing death within 90 days of medical intensive care unit from any cause (90-day all-cause mortality)(Inpatient or outpatient death within 1 to 90 days)
- Number of ABG measurements(Inpatient hospitalization (approximately 1 to 60 days))
- Number of days using a mechanical ventilator (Ventilator-days)(inpatient hospitalization (approximately 1 to 30 days))
- Number of blood transfusions received during hospitalization (packed red blood cell transfusions)(inpatient hospitalization (approximately 1 to 30 days) and receiving approximately 0 - 10 blood transfusions)
- Number of patients experiencing renal failure while hospitalized(inpatient hospitalization (approximately 1 to 30 days))
研究者
David J. Feller-Kopman
Professor of Medicine, Geisel School of Medicine Chief, Pulmonary and Critical Care Medicine
Dartmouth-Hitchcock Medical Center