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

Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05161104
• Other study ID #: K2021-10-001
• Status: Enrolling by invitation
• Start date: November 23, 2021
• Est. completion date: November 23, 2025

Study information

• Verified date: November 2021
• Source: Fujian Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: November 23, 2025
• Est. primary completion date: November 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Outcome
• Sepsis
• Toxemia

Locations

Country	Name	City	State
China	Fujian Provincial Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-hospital mortality	Number of patient deaths divided by the total number	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
Primary	28-day mortality	Number of patient deaths within 28 days divided by the total number	From patient admission to day 28
Secondary	length of stay in the ICU	Total number of days from patient transfer to ICU to transfer out of ICU	days from patient transfer to ICU to transfer out,an average of 1 week
Secondary	number of days of mechanical ventilation	Total number of days the patient was mechanically ventilated until the cessation of mechanical ventilation	Days the patient was mechanically ventilated until the cessation of mechanical ventilation,an average of 1 week