跳至主要内容
临床试验/NCT04148989
NCT04148989已完成不适用

Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care

Intermountain Health Care, Inc.3 个研究点 分布在 1 个国家目标入组 180,402 人开始时间: 2018年11月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
180,402
试验地点
3
主要终点
Door-to-antibiotic Time

研究概览

简要总结

Sepsis is a life-threatening complication of infection that can be difficult to recognize and treat promptly. Timely administration of antibiotics for emergency department (ED) patients with sepsis is challenging. The goal of this study is to determine the potential effectiveness and unintended consequences of reorganizing ED care for patients with suspected sepsis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

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

  • •Adult (age ≥18 years)
  • •ED patient at Intermountain Medical Center, Utah Valley Hospital, Dixie Regional Medical Center
  • •Arrival to study emergency department (ED) during study period of 11/13/2018 to 2/12/2021.

排除标准

  • •(1) Trauma patient

研究组 & 干预措施

Pre-implementation usual care (intervention site)

No Intervention

Adult patients age ≥18 years who receive usual care after presenting to the ED of the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation). The primary analysis will focus on the subset of patients with sepsis.

Code Sepsis post-implementation (intervention site)

Experimental

Adult patients age ≥18 years presenting to the ED of the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation). The primary analysis will focus on the subset of patients with sepsis.

干预措施: Code Sepsis protocol (full implementation) (Other)

Pre-implementation usual care (control sites)

No Intervention

Adult patients age ≥18 years who receive usual care after presenting to the ED of the control hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. The primary analysis will focus on the subset of patients with sepsis.

Post-implementation usual care (control sites)

No Intervention

Adult patients age ≥18 years who receive usual care after presenting to the ED of the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. The primary analysis will focus on the subset of patients with sepsis.

结局指标

主要结局

Door-to-antibiotic Time

时间窗: Up to 24 hours from ED arrival (an average of 3 hours)

Time from sepsis patients' emergency department arrival to intravenous (or equivalent) antibiotic initiation

次要结局

  • All-cause 1-year Mortality(1 year after ED arrival)
  • All-cause 30-day Mortality(30 days after ED arrival)
  • Hospital Length of Stay(From the time of admission to hospital discharge (up to 1 year, average 14 days))
  • Hospital Charges(From the time of admission to hospital discharge (up to 1 year, average 14 days))
  • All-cause In-hospital Mortality(From the time of admission to hospital discharge (up to 1 year, average 14 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ithan Peltan

Clinical Investigator

Intermountain Health Care, Inc.

研究点 (3)

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