Septic ShockNCT07321405
Assessment of Cardiac Output and Stroke Volume in Septic Shock Patients
An observational study of Septic Shock, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- echocardiogram and Electrical cardiometry
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 10 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients were aged more than 18 years diagnosed with septic shock following the surviving sepsis campaign -
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
osman khalaf, resident contact
About this study
Official title: Non Invasive Hemodynamic Assessment of Cardiac Output and Stroke Volume in Septic Shock Patients
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.
Read the 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.
- Conditions
- Septic Shock
- Being tested
- echocardiogram, Electrical cardiometry
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiogramDevice
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 cardiometryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| septic shock patients | echocardiography and electrical cardiometry will be applied to these patients Receives: Device: echocardiogram; Device: Electrical cardiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring cardiac output in patients with septic shock.
to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring cardiac output in patients with septic shock.
Measured: 2026-2028
cardiac output and stroke volume in septic shock patients
comparison between accuracy and reliability in assessment of cardiac out put and stroke volume using echocardiogram vs electrical cardiometer
Measured: baseline
to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring stroke volume in patients with septic shock.
to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring stroke volume in patients with septic shock.
Measured: 2026-2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Mohamed Osman Khalaf, Assiut University
- Investigators
- ahmed obeid allah, professor, Study director, Assiut Universityalaa abd elbadee, lecturer, Study chair, Assiut Universitymostafa hosney, lecturer, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321405
- Sponsor's protocol ID
- COP and SV in septic shock
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Individual data sharing
- Undecided
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.
PubMed 40082773
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Hemodynamic Assessment of Cardiac Output and Stroke Volume in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT07321405
- Acronym / sponsor ID
- COP and SV in septic shock
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| septic shock patients | – | Device: echocardiogram, Device: Electrical cardiometryechocardiography and electrical cardiometry will be applied to these patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients were aged more than 18 years diagnosed with septic shock following the surviving sepsis campaign -
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiogramTransthoracic 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 | septic shock patients |
| Electrical cardiometryElectrical 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. | Device | septic shock patients |
Primary outcome
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
to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring cardiac output in patients with septic shock.
cardiac output and stroke volume in septic shock patients
Time frame: baseline
comparison between accuracy and reliability in assessment of cardiac out put and stroke volume using echocardiogram vs electrical cardiometer
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
to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring stroke volume in patients with septic shock.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 40082773Song 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.
- https://pubmed.ncbi.nlm.nih.gov/40082773/Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
osman khalaf, resident contact
ahmed obeid allah, professor study director
Assiut University
alaa abd elbadee, lecturer study chair
Assiut University
mostafa hosney, lecturer study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osman khalaf, bachelor (01098360564, om62326232@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07321405, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.