Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:55 AM
Study NCT ID:
NCT07321405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Cardiac Output and Stroke Volume in Septic Shock Patients
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Non Invasive Hemodynamic Assessment of Cardiac Output and Stroke Volume in Septic Shock Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: