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

December 6, 2021 updated by: Xiuling Shang, Fujian Provincial Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Fujian Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
left ventricular systolic dysfunction(LVSD)
left ventricular diastolic dysfunction(LVDD)
right ventricular dysfunction(RVD)
diffuse ventricular dysfunction
hyperdynamic state left ventricular function
Normal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: From patient admission to day 28
Number of patient deaths within 28 days divided by the total number
From patient admission to day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
length of stay in the ICU
Time Frame: 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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Provincial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 23, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K2021-10-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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