SepsisNCT05624619
The Diagnostic and Prognostic Value of Speckle Tracking Imaging in Septic Cardiomyopathy
An observational study of Sepsis and Cardiomyopathies, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The aim of this study is to explore if STI technology, especially TMAD, plays an important role in evaluating left ventricular longitudinal systolic function and discriminating SICM in patients with sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Cardiomyopathies, Echocardiography
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2022to 31 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients who are diagnosed as sepsis according to sepsis 3.0 criteria, excluding those with history of organic heart disease, heart failure, atrial fibrillation or holder of cardiac implanted device
Who may be able to join
- patients who are diagnosed as sepsis according to sepsis 3.0 criteria
Who cannot join
- patients with history of organic heart disease;
- patients with history of heart failure
- holder of cardiac implanted device;
- patients with history of atrial fibrillation;
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, 200032
Jieqiong Song, 13917056745, song.jieqiong@zs-hospital.sh.cn
About this study
Official title: The Diagnostic and Prognostic Value of Speckle Tracking Imaging in Septic Cardiomyopathy: a Prospective Cohort Study
The aim of this study is to explore if STI technology, especially TMAD, plays an important role in evaluating left ventricular longitudinal systolic function and discriminating SICM in patients with sepsis. The investigators also intend to prove that TMAD may have predictive value in patients with sepsis, which is worthy of in-depth study to find strong evidence-based medical evidence for subsequent clinical practical applications.
Read the detailed description
In order to explore if STI technology, especially TMAD, plays an important role in evaluating left ventricular longitudinal systolic function and discriminating SICM in patients with sepsis, the investigators intend to explore that TMAD may have predictive value in patients with sepsis, which is worthy of in-depth study to find strong evidence-based medical evidence for subsequent clinical practical applications.
- Conditions
- Sepsis, Cardiomyopathies, Echocardiography
- Medical subject headings
- Sepsis, Cardiomyopathies
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
28-day mortality of sepsis
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start18 Dec 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2025 (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 Shanghai Zhongshan 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jieqiong Song, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624619
- Sponsor's protocol ID
- STI-01
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2022
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic and Prognostic Value of Speckle Tracking Imaging in Septic Cardiomyopathy: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05624619
- Acronym / sponsor ID
- STI-01
- Conditions
- Sepsis, Cardiomyopathies, Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 18 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Nov 2022 (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 aim of this study is to explore if STI technology, especially TMAD, plays an important role in evaluating left ventricular longitudinal systolic function and discriminating SICM in patients with sepsis. The investigators also intend to prove that TMAD may have predictive value in patients with sepsis, which is worthy of in-depth study to find strong evidence-based medical evidence for subsequent clinical practical applications.
Detailed description
In order to explore if STI technology, especially TMAD, plays an important role in evaluating left ventricular longitudinal systolic function and discriminating SICM in patients with sepsis, the investigators intend to explore that TMAD may have predictive value in patients with sepsis, which is worthy of in-depth study to find strong evidence-based medical evidence for subsequent clinical practical applications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients who are diagnosed as sepsis according to sepsis 3.0 criteria, excluding those with history of organic heart disease, heart failure, atrial fibrillation or holder of cardiac implanted device
Key inclusion criteria (1 listed)
- patients who are diagnosed as sepsis according to sepsis 3.0 criteria
Key exclusion criteria (5 listed)
- patients with history of organic heart disease;
- patients with history of heart failure
- holder of cardiac implanted device;
- patients with history of atrial fibrillation;
- refusal to participate in the study
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
28-day mortality
Time frame: 28 days
28-day mortality of sepsis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Jieqiong Song principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Cardiomyopathies, run by Shanghai Zhongshan Hospital at 1 site in China.
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 1 inclusion and 5 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jieqiong Song (13917056745, song.jieqiong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days). 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 18 Nov 2023.