EARLY-MYO-SEPSIS Registry

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04513795
• Other study ID #: EARLY-MYO-SEPSIS
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2020
• Source: RenJi Hospital
• Contact: Jun Pu, PhD, FACC, FESC
• Phone: 13817577592
• Email: pujun310[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of death, stroke, heart failure	composite of death, stroke, heart failure	2 years
Secondary	day of hospitalization	day from admission to discharge	through study completion, 2 months