NCT04606862Unknown不适用
A Non-Randomized Clinical Trial to Investigate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in the Prediction and Early Detection of Sepsis
Morley Medical0 个研究点目标入组 10,000 人开始时间: 2020年10月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 主要终点
- In-hospital sepsis prevalence
研究概览
简要总结
This is a pivotal medical device clinical trial evaluating the clinical outcomes in hospitalized patients monitored with the Morley Medical Sepsis Software Device. The device uses unique AI machine learning algorithms to analyze patient data in real time and generate clinical decision support sepsis risk predictions for clinicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Male or female patient 18 years of age or older
- •Patient is admitted or had been admitted to a participating healthcare facility
排除标准
- •Sepsis diagnosis present on admission
- •Involvement in a clinical trial of another investigational product with similar purpose
结局指标
主要结局
In-hospital sepsis prevalence
时间窗: Up to 8 weeks
In-hospital sepsis related 30-day mortality
时间窗: 30 days
次要结局
- In-hospital all-cause 30-day mortality(30 days)
- Hospital length of stay(Up to 8 weeks)
- Hospital re-admission(Up to 8 weeks)
- Time of initial IV fluids administration(Day 1 to Day 30, or until discharge)
- Time of initial vasopressors administration(Day 1 to Day 30, or until discharge)
- Time of initial antibiotics administration(Day 1 to Day 30, or until discharge)
- Time of initial blood microbiology culture(Day 1 to Day 30, or until discharge)
- Sepsis related adverse outcomes (septic shock)(Day 1 to Day 30, or until discharge)
- Sepsis prediction to onset time(Day 1 to Day 30, or until discharge)
- Sensitivity and specificity of sepsis prediction(Day 1 to Day 30, or until discharge)
研究者
相似试验
已完成
不适用
A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use MicrocatheterCoronary Artery Disease ObliterativeChronic Total Occlusion (CTO)NCT06030271Insight Lifetech Co., Ltd.60
已完成
不适用
Diode Laser for Treatment of Peri-implantitisPeri-ImplantitisImplant ComplicationNCT03383120University of Geneva, Switzerland40
Unknown
不适用
A Clinical Effectiveness Trial in Post-Operative Pterional Craniotomy Drain PlacementPterional CraniotomyNCT02792361University of Arizona90
已完成
不适用
Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF)Atrial FibrillationNCT02168972Kardium Inc.60
已完成
不适用
Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation)Dermatitis, AtopicNCT03672383Bayer42