EARLY-MYO-SEPSIS (EARLY Assessment of MYOcardial Injury in Sepsis Patient) Registry
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- composite of death, stroke, heart failure
研究概览
简要总结
The diagnosis and pathophysiology of sepsis-induced cardiac dysfunction remain unknown. This registry is to evaluate characteristics of sepsis patients by multi-modalities imaging, including echocardiography, cardiovascular magnetic resonance imaging in 300 patients in 5 sites. Subjects will be followed up to 2 years.
详细描述
Approximately 20-30 million patients worldwide suffer from sepsis every year, which is increasing at the rate of 8% to 13% per year. It is possible that sepsis progress to multiple organ dysfunction in the early stage, with a fatality of 30% to 60%. Myocardium is one of the most vulnerable tissue under the abnormal 'inflammation storm'.Cardiac dysfunction is one of the important predictors for mortality of sepsis.Patients with myocardial depression have an apparently higher mortality rate (70%) as compared with septic patients without cardiac impairment (20%).
Although several trials had explored the diagnosis and treatment of sepsis-induced cardiac dysfunction, the effective characteristic depict and effective therapy remain incompletely understand.
This is a prospective, multi-center, non-randomized, observational registry study of sepsis patients that undergo multi-modality imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patiants meets the criteria of Sepsis 3.0 as below:
- •Sepsis is a lifethreatening organ dysfunction caused by a dysregulated host response to infection
- •1 patients in ICU：
- •1.1 have at least one organ dysfunction
- •1.2 SOFA score ≥2
- •2 patients not in ICU
- •2.1 have at least one organ dysfunction
- •2.2 SOFA score or qSOFA score ≥2
排除标准
- •Patient who is unable to comply with the follow-up schedule.
- •Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.
- •Patient has a life expectancy of less than 6 months due to any condition
结局指标
主要结局
composite of death, stroke, heart failure
时间窗: 2 years
composite of death, stroke, heart failure
次要结局
- day of hospitalization(through study completion, 2 months)