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EARLY-MYO-SEPSIS Registry

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Sepsis

Study type

Observational

Funder types

Other

Identifiers

NCT04513795
EARLY-MYO-SEPSIS

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

Under 85 years old

Volunteers

No Healthy Volunteers

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.
    1. Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.
    1. Patient has a life expectancy of less than 6 months due to any condition

Trial contacts and locations

0

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Central trial contact

Lingcong Kong; Jun Pu, PhD, FACC, FESC

Data sourced from clinicaltrials.gov

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