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EARLY-MYO-SEPSIS Registry

EARLY-MYO-SEPSIS (EARLY Assessment of MYOcardial Injury in Sepsis Patient) Registry

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04513795
Enrollment
300
Registered
2020-08-14
Start date
2020-09-01
Completion date
2023-08-31
Last updated
2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Interventions

None listed

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 85 Years
Healthy volunteers
No

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

* 1\. Patient who is unable to comply with the follow-up schedule. * 2\. Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study. * 3\. Patient has a life expectancy of less than 6 months due to any condition

Design outcomes

Primary

MeasureTime frameDescription
composite of death, stroke, heart failure2 yearscomposite of death, stroke, heart failure

Secondary

MeasureTime frameDescription
day of hospitalizationthrough study completion, 2 monthsday from admission to discharge

Contacts

Primary ContactJun Pu, PhD, FACC, FESC
pujun310@hotmail.com13817577592
Backup ContactLingcong Kong
avrilblanche373@126.com13857766365

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026