- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07321405
Assessment of Cardiac Output and Stroke Volume in Septic Shock Patients
Non Invasive Hemodynamic Assessment of Cardiac Output and Stroke Volume in Septic Shock Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Osman khalaf, bachelor
- Phone Number: 01098360564
- Email: om62326232@gmail.com
Study Contact Backup
- Name: osman khalaf, resident
- Phone Number: 01098360564
Study Locations
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Asyut, Egypt, 71511
- Assiut University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
patients were aged more than 18 years diagnosed with septic shock following the surviving sepsis campaign
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Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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septic shock patients
echocardiography and electrical cardiometry will be applied to these patients
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring cardiac output in patients with septic shock.
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2026-2028
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cardiac output and stroke volume in septic shock patients
Time Frame: baseline
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comparison between accuracy and reliability in assessment of cardiac out put and stroke volume using echocardiogram vs electrical cardiometer
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baseline
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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
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to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring stroke volume in patients with septic shock.
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2026-2028
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: ahmed obeid allah, professor, Assiut University
- Study Chair: alaa abd elbadee, lecturer, Assiut University
- Study Chair: mostafa hosney, lecturer, Assiut University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Sepsis
- Systemic Inflammatory Response Syndrome
- Inflammation
- Shock
- Pathological Conditions, Signs and Symptoms
- Shock, Septic
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Cardiac Imaging Techniques
- Ultrasonography
- Echocardiography
Other Study ID Numbers
- COP and SV in septic shock
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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