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

Sponsor
Fujian Provincial Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05161104
Collaborator
(none)
200
1
48
4.2

Study Details

Study Description

Brief 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Crossover
Time Perspective:
Cross-Sectional
Official Title:
A Multicenter Cross-sectional Study of Cardiac Ultrasound Phenotypes in Patients With Sepsis
Actual Study Start Date :
Nov 23, 2021
Anticipated Primary Completion Date :
Nov 23, 2024
Anticipated Study Completion Date :
Nov 23, 2025

Arms and Interventions

Arm Intervention/Treatment
left ventricular systolic dysfunction(LVSD)

left ventricular diastolic dysfunction(LVDD)

right ventricular dysfunction(RVD)

diffuse ventricular dysfunction

hyperdynamic state left ventricular function

Normal

Outcome Measures

Primary Outcome Measures

  1. in-hospital mortality [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

  2. 28-day mortality [From patient admission to day 28]

    Number of patient deaths within 28 days divided by the total number

Secondary Outcome Measures

  1. length of stay in the ICU [days from patient transfer to ICU to transfer out,an average of 1 week]

    Total number of days from patient transfer to ICU to transfer out of ICU

  2. number of days of mechanical ventilation [Days the patient was mechanically ventilated until the cessation of mechanical ventilation,an average of 1 week]

    Total number of days the patient was mechanically ventilated until the cessation of mechanical ventilation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fujian Provincial Hospital Fuzhou Fujian China 350000

Sponsors and Collaborators

  • Fujian Provincial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiuling Shang, Clinical Professor, Fujian Provincial Hospital
ClinicalTrials.gov Identifier:
NCT05161104
Other Study ID Numbers:
  • K2021-10-001
First Posted:
Dec 16, 2021
Last Update Posted:
Dec 16, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2021