Cardiac Ultrasound PhenotypesNCT05161104
A Multicenter Cross-sectional Study of Cardiac Ultrasound Phenotypes in Patients With Sepsis
An observational study of Cardiac Ultrasound Phenotypes and Septic Myocardial Suppression, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
The heart, one of the most important organs for oxygen supply and consumption, is frequently involved in sepsis, i.e. septic cardiomyopathy, also known as septic myocardial suppression. The occurrence of septic myocardial suppression increases mortality in septic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Ultrasound Phenotypes, Septic Myocardial Suppression, Hyperdynamic State Left Ventricular Function in Sepsis Patients
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2021to 23 Nov 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: All patients with sepsis or septic shock who conform to Sepsis 3.0 diagnostic criteria and were more than or equal to 18 years of age who were admitted to each center were included. Sepsis was defined as an increase of ≥2 points from baseline in sequential organ failure assessment (SOFA) score due to infection; septic shock was defined as persistent hypotension on top of sepsis, requiring vasoactive drugs to maintain a mean arterial pressure(MAP) ≥65 mmHg and a blood lactate level >2 mmol/L despite adequate fluid resuscitation.
Who may be able to join
- All patients with sepsis or septic shock who conform to Sepsis 3.0 diagnostic criteria
Who cannot join
- Patients with preexisting chronic heart disease such as cardiomyopathy, chronic pulmonary heart disease, severe cardiac valve disease, coronary heart disease, congenital heart disease, pericardial disease, etc. and with cardiac function ≥ grade III (NYHA classification) prior to sepsis.
- End-stage malignancies.
- Severe trauma.
- Pregnancy.
- Patients for whom transthoracic echocardiography data are not available.
Trial locations and contacts
1 site in 1 country.
About this study
The heart, one of the most important organs for oxygen supply and consumption, is frequently involved in sepsis, i.e. septic cardiomyopathy, also known as septic myocardial suppression. The occurrence of septic myocardial suppression increases mortality in septic patients. Recent studies have found that left ventricular hyperdynamic state (EF > 70%) is associated with intra-ICU mortality in septic patients, possibly because it reflects unresolved vascular paralysis from sepsis . For septic myocardial suppression, there is still a lack of uniform criteria for diagnosis, but it is well established that the cardiac ultrasound phenotype of septic myocardial suppression can be left ventricular systolic insufficiency (LVSD), left ventricular diastolic insufficiency (LVDD), right ventricular insufficiency (RVD), diffuse ventricular insufficiency, and mixed ventricular insufficiency. According to incomplete statistics, the prevalence of LVSD ranges from 12 to 60%, the prevalence of LVDD is higher, 20% to 79%, and the prevalence of RVD varies from 30% to 55%. However, based on the current understanding of septic myocardial suppression, the relationship between each staging and its prognosis is unclear, and echocardiography can rapidly identify septic myocardial suppression and guide the classification of septic myocardial suppression to further optimize the diagnosis and treatment process of sepsis, especially to avoid over-resuscitation during fluid resuscitation and perform reverse resuscitation in a timely manner to improve patient prognosis and reduce hospitalization time. The aim of this study is to classify and evaluate the prognosis of patients with different septic cardiac ultrasound phenotypes in multiple centers across China by measuring the right and left heart systolic and diastolic indices by echocardiography, recording the baseline conditions and clinical indices of patients, and combining them with the prognosis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| left ventricular systolic dysfunction(LVSD) | Not described | |
| left ventricular diastolic dysfunction(LVDD) | Not described | |
| right ventricular dysfunction(RVD) | Not described | |
| diffuse ventricular dysfunction | Not described | |
| hyperdynamic state left ventricular function | Not described | |
| Normal | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
Number of patient deaths divided by the total number
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
28-day mortality
Number of patient deaths within 28 days divided by the total number
Measured: From patient admission to day 28
Secondary outcomes (2)
length of stay in the ICU
Total number of days from patient transfer to ICU to transfer out of ICU
Measured: days from patient transfer to ICU to transfer out，an average of 1 week
number of days of mechanical ventilation
Total number of days the patient was mechanically ventilated until the cessation of mechanical ventilation
Measured: Days the patient was mechanically ventilated until the cessation of mechanical ventilation，an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start23 Nov 2021
- Primary completion23 Nov 2024 (estimated)
- Study completion23 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Ultrasound PhenotypesStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuling Shang, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161104
- Sponsor's protocol ID
- K2021-10-001
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang H, Wang X, Yin W, Zhang H, Liu L, Pan P, Zhu Y, Huang W, Xing Z, Yao B, Wang C, Lin T, Yu R, Shang X. A multicenter prospective cohort study of cardiac ultrasound phenotypes in patients with sepsis: Study protocol for a multicenter prospective cohort trial. Front Med (Lausanne). 2022 Jul 27;9:938536. doi: 10.3389/fmed.2022.938536. eCollection 2022.
PubMed 35966841
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Cross-sectional Study of Cardiac Ultrasound Phenotypes in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT05161104
- Acronym / sponsor ID
- K2021-10-001
- Conditions
- Cardiac Ultrasound Phenotypes, Septic Myocardial Suppression, Hyperdynamic State Left Ventricular Function in Sepsis Patients, Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 23 Nov 2024 (estimated)
- Study completion
- 23 Nov 2025 (estimated)
- First posted
- 16 Dec 2021 (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 heart, one of the most important organs for oxygen supply and consumption, is frequently involved in sepsis, i.e. septic cardiomyopathy, also known as septic myocardial suppression. The occurrence of septic myocardial suppression increases mortality in septic patients. Recent studies have found that left ventricular hyperdynamic state (EF > 70%) is associated with intra-ICU mortality in septic patients, possibly because it reflects unresolved vascular paralysis from sepsis . For septic myocardial suppression, there is still a lack of uniform criteria for diagnosis, but it is well established that the cardiac ultrasound phenotype of septic myocardial suppression can be left ventricular systolic insufficiency (LVSD), left ventricular diastolic insufficiency (LVDD), right ventricular insufficiency (RVD), diffuse ventricular insufficiency, and mixed ventricular insufficiency. According to incomplete statistics, the prevalence of LVSD ranges from 12 to 60%, the prevalence of LVDD is higher, 20% to 79%, and the prevalence of RVD varies from 30% to 55%. However, based on the current understanding of septic myocardial suppression, the relationship between each staging and its prognosis is unclear, and echocardiography can rapidly identify septic myocardial suppression and guide the classification of septic myocardial suppression to further optimize the diagnosis and treatment process of sepsis, especially to avoid over-resuscitation during fluid resuscitation and perform reverse resuscitation in a timely manner to improve patient prognosis and reduce hospitalization time. The aim of this study is to classify and evaluate the prognosis of patients with different septic cardiac ultrasound phenotypes in multiple centers across China by measuring the right and left heart systolic and diastolic indices by echocardiography, recording the baseline conditions and clinical indices of patients, and combining them with the prognosis.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| left ventricular systolic dysfunction(LVSD) | – | – |
| left ventricular diastolic dysfunction(LVDD) | – | – |
| right ventricular dysfunction(RVD) | – | – |
| diffuse ventricular dysfunction | – | – |
| hyperdynamic state left ventricular function | – | – |
| Normal | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with sepsis or septic shock who conform to Sepsis 3.0 diagnostic criteria and were more than or equal to 18 years of age who were admitted to each center were included. Sepsis was defined as an increase of ≥2 points from baseline in sequential organ failure assessment (SOFA) score due to infection; septic shock was defined as persistent hypotension on top of sepsis, requiring vasoactive drugs to maintain a mean arterial pressure(MAP) ≥65 mmHg and a blood lactate level >2 mmol/L despite adequate fluid resuscitation.
Key inclusion criteria (1 listed)
- All patients with sepsis or septic shock who conform to Sepsis 3.0 diagnostic criteria
Key exclusion criteria (5 listed)
- Patients with preexisting chronic heart disease such as cardiomyopathy, chronic pulmonary heart disease, severe cardiac valve disease, coronary heart disease, congenital heart disease, pericardial disease, etc. and with cardiac function ≥ grade III (NYHA classification) prior to sepsis.
- End-stage malignancies.
- Severe trauma.
- Pregnancy.
- Patients for whom transthoracic echocardiography data are not available.
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
in-hospital mortality
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Number of patient deaths divided by the total number
28-day mortality
Time frame: From patient admission to day 28
Number of patient deaths within 28 days divided by the total number
2 secondary outcomes
length of stay in the ICU
Time frame: days from patient transfer to ICU to transfer out，an average of 1 week
number of days of mechanical ventilation
Time frame: Days the patient was mechanically ventilated until the cessation of mechanical ventilation，an average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Derived from this study: PubMed 35966841Zhang H, Wang X, Yin W, Zhang H, Liu L, Pan P, Zhu Y, Huang W, Xing Z, Yao B, Wang C, Lin T, Yu R, Shang X. A multicenter prospective cohort study of cardiac ultrasound phenotypes in patients with sepsis: Study protocol for a multicenter prospective cohort trial. Front Med (Lausanne). 2022 Jul 27;9:938536. doi: 10.3389/fmed.2022.938536. eCollection 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Ultrasound Phenotypes and Septic Myocardial Suppression, run by Fujian Provincial 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 16 Dec 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161104, which also lists 1 linked publication.
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 16 Dec 2021.