NCT03231956Unknown不适用
Noninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)
Edwards Lifesciences5 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2017年6月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 182
- 试验地点
- 5
- 主要终点
- Venous Blood Lactate clearance
研究概览
简要总结
To investigate the relationship between initial ClearSight™ derived hemodynamic parameters and outcomes (death, ongoing organ dysfunction or delayed ICU admission) in patients with acute infection and possible sepsis, with a focus on venous blood lactate (< 2.0, 2.0-3.9, and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic Group).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •≥ 18 years of age at the time of enrollment
- •Any combination of acute symptoms and signs that the treating ED physician, after initial history and physical examination, attributes to a systemic infection
- •ED Physician confirms likely hospital admission (> 50%) due to suspicion of infection
- •ED Physician confirms intention to order both blood cultures and venous blood lactate levels
- •Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation
排除标准
- •Initial venous blood lactate measured > 3 hours after ED arrival
- •Pre-existing infection for which patient is being treated with antibiotics as an outpatient
- •Prisoners
- •Pregnant women
- •Any previous medical condition with life expectancy of < 3 months (patients with ESRD and heart failure are not excluded)
- •DNR or comfort care order preexisting to ED visit or established in the ED
- •Palliative care or hospice consult in the ED
- •Known severe aortic insufficiency
- •Known history of Raynaud's disease
- •Poor follow-up candidate in the opinion of the Investigator
- •Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection.
- •Control Sepsis Mimic
- •Inclusion Criteria:
- •≥18 years of age at the time of enrollment
- •Presents to the ED with a chief complaint consistent with a minor infection (upper respiratory infection, soft tissue infection, viral infection) or an asthma or COPD exacerbation on whom the treating physician is not ordering labs for blood cultures or lactate levels
- •Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation.
- •Exclusion Criteria:
- •Pre-existing infection for which patient is being treated with antibiotics as an outpatient
- •Prisoners
- •Pregnant women
- •Any previous medical condition with life expectancy of < 3 months (patients with ESRD and heart failure are not excluded)
- •DNR or comfort care order preexisting to ED visit or established in the ED
- •Palliative care or hospice consult in the ED
- •Known severe aortic insufficiency
- •Known history of Raynaud's disease
- •Poor follow-up candidate in the opinion of the Investigator
- •Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection.
- •Treating physician is planning on ordering either a lactate or blood cultures on the patient.
结局指标
主要结局
Venous Blood Lactate clearance
时间窗: Within 24 and 72 hours of presentation
Venous Blood Lactate clearance
Composite outcome
时间窗: Within 72 hours of presentation
Increase in modified Sequential Organ Failure Assessment (mSOFA) score ≥ 1 resulting in ICU admission / death.
Length of Stay
时间窗: 30 days
Emergency Department length of stay, ICU length of stay, and Hospital length of stay
Recidivism
时间窗: 30 days
Recidivism within 30 days of the index hospital visit
次要结局
未报告次要终点
研究者
研究点 (5)
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