Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65,250
- 试验地点
- 2
- 主要终点
- All-cause hospital mortality by day 90
研究概览
简要总结
Screening for sepsis has been recommended by the Surviving Sepsis Campaign Clinical Practice Guidelines to facilitate early identification and early management of sepsis. However, the optimal tool remains unknown.The objective of this trial is to examine the effect of an electronic sepsis alert tool on reducing hospital mortailty in patients admitted to medical-surgical-oncology wards.
详细描述
The study aims to examine the effect of screening for sepsis using an electronic sepsis alert versus no alert in hospitalized patients admitted to wards using an active sepsis alert system compared with wards with no active (masked) sepsis alert system on hospital mortality by day 90.
The wards will be randomized in a stepped-wedge cluster fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
盲法说明
The electronic alert will be masked on the control wards.
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient wards, defined as wards used to manage inpatients, in the five Ministry of National Guard Health Affairs (MNGHA) hospitals, Kingdom of Saudi Arabia
排除标准
- •Cardiology, transplant, pediatric, obstetric wards
- •Intensive Care Units and Emergency Department
- •Operating rooms
- •Outpatients
- •Day care wards, endoscopy, outpatient procedure areas, hemodialysis units.
- •Patient level inclusion and exclusion criteria
- •Inclusion Criteria:
- •Aged 14 years or older
- •Checked in as inpatient status to one of the study ward
- •Exclusion Criteria:
- •No commitment for full life support on the time of arrival to the study ward
结局指标
主要结局
All-cause hospital mortality by day 90
时间窗: 90 Day
Percentage of all-cause hospital mortality
次要结局
- The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy(90 Day)
- Antibiotic-free days(90 Day)
- Clostridium difficile infection(90 Day)
- Cardiac arrest(90 Day)
- The acquisition of MDROs(90 Day)
- ICU-free days(90 Day)
- Critical care response team activation(90 Day)
- Hospital length of stay(90 Day)
- Transfer to ICU(90 Day)
研究者
Dr Yaseen Arabi
Chairman intensive care unit
King Abdullah International Medical Research Center