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A Multicenter Cross-sectional Study of Cardiac Ultrasound Phenotypes in Patients With Sepsis

NCT ID: NCT05161104

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-23

Study Completion Date

2025-11-23

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Ultrasound Phenotypes Septic Myocardial Suppression Hyperdynamic State Left Ventricular Function in Sepsis Patients Outcome

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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left ventricular systolic dysfunction(LVSD)

No interventions assigned to this group

left ventricular diastolic dysfunction(LVDD)

No interventions assigned to this group

right ventricular dysfunction(RVD)

No interventions assigned to this group

diffuse ventricular dysfunction

No interventions assigned to this group

hyperdynamic state left ventricular function

No interventions assigned to this group

Normal

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- All patients with sepsis or septic shock who conform to Sepsis 3.0 diagnostic criteria

Exclusion Criteria

1. 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.
2. End-stage malignancies.
3. Severe trauma.
4. Pregnancy.
5. Patients for whom transthoracic echocardiography data are not available.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Provincial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiuling Shang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fujian Provincial Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 35966841 (View on PubMed)

Other Identifiers

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K2021-10-001

Identifier Type: -

Identifier Source: org_study_id