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Not yet recruiting NCT07321405

Assessment of Cardiac Output and Stroke Volume in Septic Shock Patients

— Observational Septic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: echocardiogram, Electrical cardiometry.
Who it may be relevant to
Registry conditions: Septic Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Non Invasive Hemodynamic Assessment of Cardiac Output and Stroke Volume in Septic Shock Patients

Overview

The aim of this research is to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring cardiac output and stroke volume in patients with septic shock, to evaluate the potential of EC as a non-invasive alternative for hemodynamic monitoring.

Detailed description

Sepsis is a life-threatening condition caused by a dysregulated immune response to infection, leading to organ dysfunction. It remains a leading global cause of morbidity and mortality, often progressing rapidly to septic shock and multi-organ failure if not promptly diagnosed and treated.

The complex pathophysiology involves systemic inflammation, endothelial damage, and impaired tissue perfusion, making early recognition and hemodynamic stabilization vital for survival. Accurate monitoring of cardiac function plays a key role in managing septic patients.

Cardiac output (CO) and stroke volume (SV) are key hemodynamic parameters guiding therapy in critically ill patients, particularly those with pneumonia and septic shock, who experience severe circulatory and respiratory dysfunction contributing to their high mortality.

Transthoracic echocardiography (TTE) is the gold standard for non-invasive bedside assessment of CO and SV, providing precise evaluation of cardiac structure and flow. However, TTE requires operator expertise, can be time-consuming, and may be limited by patient-specific factors.

Electrical cardiometry (EC) is an emerging non-invasive bio-impedance technique offering continuous monitoring with easier application and less operator dependency. Despite its advantages, EC's accuracy and reliability in critically ill septic patients require further validation.

Currently, hemodynamic monitoring mainly relies on clinical assessment combined with intermittent TTE, with invasive methods reserved for selective cases; EC holds potential as a simpler, safer alternative warranting further investigation.

Interventions

  • Device echocardiogram
    Transthoracic echocardiography (TTE) is the gold standard for non-invasive bedside assessment of CO and SV, providing precise evaluation of cardiac structure and flow. However, TTE requires operator expertise, can be time-consuming, and may be limited by patient-specific factors.
  • Device Electrical cardiometry
    Electrical cardiometry (EC) is an emerging non-invasive bio-impedance technique offering continuous monitoring with easier application and less operator dependency. Despite its advantages, EC's accuracy and reliability in critically ill septic patients require further validation.

Primary outcome measures

  • to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring cardiac output in patients with septic shock. [Time frame: 2026-2028]
  • cardiac output and stroke volume in septic shock patients [Time frame: baseline]
  • to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring stroke volume in patients with septic shock. [Time frame: 2026-2028]

Eligibility criteria

Inclusion Criteria: patients aged more than 18 years must be diagnosed with septic shock following the surviving sepsis campaign

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Exclusion criteria

  • patients aged less than 18 years pregnant women cases suffering cardiac diseases (heart failure, arrhythmia, moderate, and severe valvular disease) patients with poor quality echocardiographic images and measurements

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Assiut University Hospital — Asyut

Publications

  • Song W, Guo J, Cao D, Jiang J, Yang T, Ma X, Yuan H, Wu J, Guan X, Si X. Comparison of noninvasive electrical cardiometry and transpulmonary thermodilution for cardiac output measurement in critically ill patients: a prospective observational study. BMC Anesthesiol. 2025 Mar 13;25(1):123. doi: 10.1186/s12871-025-03005-1. PMID 40082773

Identifiers

NCT: NCT07321405 · COP and SV in septic shock

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗