EARLY-MYO-SEPSIS (EARLY Assessment of MYOcardial Injury in Sepsis Patient) Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- RenJi Hospital
- Enrollment
- 300
- Primary Endpoint
- composite of death, stroke, heart failure
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
composite of death, stroke, heart failure
Time Frame: 2 years
composite of death, stroke, heart failure
Secondary Outcomes
- day of hospitalization(through study completion, 2 months)