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. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Sepsis
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients were diagnosed as sepsis or suspected as sepsis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: EARLY-MYO-SEPSIS (EARLY Assessment of MYOcardial Injury in Sepsis Patient) Registry
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.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of death, stroke, heart failure
composite of death, stroke, heart failure
Measured: 2 years
Secondary outcomes (1)
day of hospitalization
day from admission to discharge
Measured: through study completion, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513795
- Sponsor's protocol ID
- EARLY-MYO-SEPSIS
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY-MYO-SEPSIS (EARLY Assessment of MYOcardial Injury in Sepsis Patient) Registry
- ClinicalTrials.gov ID
- NCT04513795
- Acronym / sponsor ID
- EARLY-MYO-SEPSIS
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients were diagnosed as sepsis or suspected as sepsis
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
composite of death, stroke, heart failure
Time frame: 2 years
composite of death, stroke, heart failure
1 secondary outcome
day of hospitalization
Time frame: through study completion, 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Pu, PhD, FACC, FESC (13817577592, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite of death, stroke, heart failure (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.