NCT04513795

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 10, 2020

Last Update Submit

August 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • composite of death, stroke, heart failure

    composite of death, stroke, heart failure

    2 years

Secondary Outcomes (1)

  • day of hospitalization

    through study completion, 2 months

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients were diagnosed as sepsis or suspected as sepsis

You may qualify if:

  • Patiants meets the criteria of Sepsis 3.0 as below:
  • Sepsis is a lifethreatening organ dysfunction caused by a dysregulated host response to infection
  • patients in ICU:
  • have at least one organ dysfunction
  • SOFA score ≥2
  • patients not in ICU
  • have at least one organ dysfunction
  • SOFA score or qSOFA score ≥2

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jun Pu, PhD, FACC, FESC

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 14, 2020

Study Start

September 1, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2023

Last Updated

August 14, 2020

Record last verified: 2020-08