CClinicalTrials.gg
Status unknownNCT04513795Updated Aug 14, 2020

EARLY-MYO-SEPSIS Registry

An observational study in Sepsis, sponsored by RenJi Hospital. Status unknown. Open to participants aged Up to 85 Years. Per ClinicalTrials.gov, last updated 2020-08-14.

Sponsored by RenJi Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
Up to 85 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Sepsis

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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 300 is above the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients were diagnosed as sepsis or suspected as sepsis

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. composite of death, stroke, heart failure

    composite of death, stroke, heart failure

    Time frame: 2 years

Secondary outcomes

  1. day of hospitalization

    day from admission to discharge

    Time frame: through study completion, 2 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04513795
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Aug 14, 2020
Start date
Sep 1, 2020 (estimated)
Primary completion
Aug 31, 2022 (estimated)
Completion
Aug 31, 2023 (estimated)
Last update
Aug 14, 2020

Study contacts

Jun Pu, PhD, FACC, FESC
Contact
pujun310@hotmail.com
13817577592
Lingcong Kong
Contact
avrilblanche373@126.com
13857766365

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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