Septic ShockNCT07411469
Comparison Between Using Cardiometry and IVC Collapsibility
An observational study of Septic Shock, run by Menoufia University at 1 site in Egypt.
Trial summary
Sepsis is a life-threatening condition caused by a dysregulated host response to infection, leading to organ dysfunction. Septic shock, a severe form of sepsis, is characterized by persistent hypotension and cellular/metabolic abnormalities despite adequate fluid resuscitation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Cardiometry
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2025to 20 May 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study protocol approval prior to implementation of the research will be obtained from Faculty of Medicine, Menoufia University Research Ethics Committee. Parents were informed about the study purpose and its consequences, confirming confidentiality of data. A signed informed consent was a pre-requisite for the study. Type of study: Prospective study Site of study: This study will be conducted at the Intensive Care Unit, Faculty of Medicine, Menoufia university Hospital. The study population: The study will include (60) septic Shock patients who admitted to Intensive Care Unit.
Who may be able to join
- Patients Diagnosed with Hypotensive Sepsis: Patients must meet the clinical criteria for sepsis according to the Sepsis-3 definitions, including evidence of infection and hypotension despite adequate fluid resuscitation. Hypotension is defined as systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <65 mmHg.
- BMI ≥18.5 and ≤40 kg/m²: Patients will be included regardless of BMI, as long as it falls within the normal to overweight/obese range. Extremes of BMI (e.g., <18.5 or >40) may be excluded due to the potential influence on peripheral perfusion measurements.
- American Society of Anesthesiologists (ASA) Physical Status Classification as:
- ASA Score I-III: Patients with an ASA physical status score of I (healthy patients), II (mild systemic disease), or III (severe systemic disease) will be included. Patients with ASA IV or V (those with severe systemic disease that is a constant threat to life) will be excluded due to potential confounding factors.
Who cannot join
- Cardiac Conditions: Significant valvular heart diseases, such as severe mitral or aortic regurgitation, which can affect hemodynamic assessments.
- Presence of major cardiac arrhythmias, including atrial fibrillation or frequent ectopic beats, as these can interfere with accurate measurement of fluid responsiveness.
- Renal Considerations: Patients undergoing renal replacement therapy or those with end-stage renal disease, as fluid balance and responsiveness may be altered.
- Pregnancy Hemodynamic changes during pregnancy (e.g., increased cardiac output and altered vascular resistance) differ significantly from septic shock.
- Patients with a body mass index (BMI) greater than 40 kg/m² Obesity can affect the accuracy of non-invasive monitoring techniques with poor window.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia University Hospital
Shibīn al Kawm, Menoufia, 23511
Noha Abdallah Afify, Professor, +201069113014, nohaafify2014@gmail.com
Marwa Abdelmonem Abdallah, Lecturer, +201092646406, marwamarwamarwa88@yahoo.com
About this study
Official title: Comparison Between Using Cardiometry and IVC Collapsibility in Predicting Fluid Responsiveness in Hypovolemic Sepsis Patients
Sepsis is a life-threatening condition caused by a dysregulated host response to infection, leading to organ dysfunction. Septic shock, a severe form of sepsis, is characterized by persistent hypotension and cellular/metabolic abnormalities despite adequate fluid resuscitation. It is associated with high mortality rates globally, necessitating timely diagnosis and treatment. Fluid resuscitation and vasopressor use are cornerstones of management, but they must be tailored to the individual to prevent complications such as fluid overload.
Read the detailed description
Predicting fluid responsiveness in critically ill patients is crucial to optimizing fluid therapy. Traditional static measures like central venous pressure (CVP) are unreliable, while dynamic indices such as stroke volume variation (SVV) and pulse pressure variation (PPV) are considered more accurate but limited to specific conditions. Novel, non-invasive tools for predicting fluid responsiveness are particularly valuable in heterogeneous patient populations, including those with spontaneous breathing or arrhythmias.
Non-invasive cardiometry, utilizing advanced hemodynamic monitoring technologies, offers another method to assess fluid responsiveness. By measuring parameters such as stroke volume and cardiac output, non-invasive cardiometry provides real-time insights into a patient's hemodynamic status without the need for invasive procedures. This approach has the potential to guide fluid management effectively, especially in critically ill patients where invasive monitoring may pose additional risks.
Electrical cardiometry (EC) was introduced as a new bio impedance method with the new algorithm for processing the impedance signal to overcome the limitations associated with bio impedance which are used to measure and calculate hemodynamic parameters as cardiac output, cardiac index, SV and systemic vascular resistance index.
- Conditions
- Septic Shock
- Being tested
- 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.
CardiometryProcedure or surgery
Also called Inferior Vena Cava Ultrasound Assessment
Bedside ultrasound measurement of inferior vena cava diameters during the respiratory cycle to calculate the collapsibility index at baseline and after fluid challenge
| Study group | Role | What they receive |
|---|---|---|
| Electrical Cardiometry Monitoring | Non-invasive assessment of stroke volume and cardiac output using electrical cardiometry at baseline and after fluid challenge. Receives: Procedure: Cardiometry | |
| Inferior Vena Cava Collapsibility Assessment Group | Thirty patients with septic shock will undergo bedside ultrasound assessment of the inferior vena cava to measure the collapsibility index for evaluation of fluid responsiveness. Measurements will be performed as part of routine clinical monitoring without any alteration to standard clinical management. Receives: Procedure: Cardiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Septic Shock Evaluation
Assessment of the participants which suffering from Septic Shock by using Inferior Vena Cava Collapsibility and Electrical Cardiometry for assisting the Fluid Responsiveness
Measured: Two Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start10 May 2025
- Primary completion10 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Fared, Menoufia University
- Investigators
- Noha Abdallah Afify, Professor, Study chair, Anaesthesia, Intensive Care and Pain Management, Faculty of Medicine, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411469
- Sponsor's protocol ID
- Cardiometry and IVC
- Status last verified
- May 2025
- First submitted
- 30 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Using Cardiometry and IVC Collapsibility in Predicting Fluid Responsiveness in Hypovolemic Sepsis Patients
- ClinicalTrials.gov ID
- NCT07411469
- Acronym / sponsor ID
- Cardiometry and IVC
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 10 May 2025 (actual)
- Primary completion
- 10 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 13 Feb 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.
Sepsis is a life-threatening condition caused by a dysregulated host response to infection, leading to organ dysfunction. Septic shock, a severe form of sepsis, is characterized by persistent hypotension and cellular/metabolic abnormalities despite adequate fluid resuscitation. It is associated with high mortality rates globally, necessitating timely diagnosis and treatment. Fluid resuscitation and vasopressor use are cornerstones of management, but they must be tailored to the individual to prevent complications such as fluid overload.
Detailed description
Predicting fluid responsiveness in critically ill patients is crucial to optimizing fluid therapy. Traditional static measures like central venous pressure (CVP) are unreliable, while dynamic indices such as stroke volume variation (SVV) and pulse pressure variation (PPV) are considered more accurate but limited to specific conditions. Novel, non-invasive tools for predicting fluid responsiveness are particularly valuable in heterogeneous patient populations, including those with spontaneous breathing or arrhythmias.
Non-invasive cardiometry, utilizing advanced hemodynamic monitoring technologies, offers another method to assess fluid responsiveness. By measuring parameters such as stroke volume and cardiac output, non-invasive cardiometry provides real-time insights into a patient's hemodynamic status without the need for invasive procedures. This approach has the potential to guide fluid management effectively, especially in critically ill patients where invasive monitoring may pose additional risks.
Electrical cardiometry (EC) was introduced as a new bio impedance method with the new algorithm for processing the impedance signal to overcome the limitations associated with bio impedance which are used to measure and calculate hemodynamic parameters as cardiac output, cardiac index, SV and systemic vascular resistance index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical Cardiometry Monitoring | – | Procedure: CardiometryNon-invasive assessment of stroke volume and cardiac output using electrical cardiometry at baseline and after fluid challenge. |
| Inferior Vena Cava Collapsibility Assessment Group | – | Procedure: CardiometryThirty patients with septic shock will undergo bedside ultrasound assessment of the inferior vena cava to measure the collapsibility index for evaluation of fluid responsiveness. Measurements will be performed as part of routine clinical monitoring without any alteration to standard clinical management. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study protocol approval prior to implementation of the research will be obtained from Faculty of Medicine, Menoufia University Research Ethics Committee. Parents were informed about the study purpose and its consequences, confirming confidentiality of data. A signed informed consent was a pre-requisite for the study. Type of study: Prospective study Site of study: This study will be conducted at the Intensive Care Unit, Faculty of Medicine, Menoufia university Hospital. The study population: The study will include (60) septic Shock patients who admitted to Intensive Care Unit.
Key inclusion criteria (4 listed)
- Patients Diagnosed with Hypotensive Sepsis: Patients must meet the clinical criteria for sepsis according to the Sepsis-3 definitions, including evidence of infection and hypotension despite adequate fluid resuscitation. Hypotension is defined as systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <65 mmHg.
- BMI ≥18.5 and ≤40 kg/m²: Patients will be included regardless of BMI, as long as it falls within the normal to overweight/obese range. Extremes of BMI (e.g., <18.5 or >40) may be excluded due to the potential influence on peripheral perfusion measurements.
- American Society of Anesthesiologists (ASA) Physical Status Classification as:
- ASA Score I-III: Patients with an ASA physical status score of I (healthy patients), II (mild systemic disease), or III (severe systemic disease) will be included. Patients with ASA IV or V (those with severe systemic disease that is a constant threat to life) will be excluded due to potential confounding factors.
Key exclusion criteria (5 listed)
- Cardiac Conditions: Significant valvular heart diseases, such as severe mitral or aortic regurgitation, which can affect hemodynamic assessments.
- Presence of major cardiac arrhythmias, including atrial fibrillation or frequent ectopic beats, as these can interfere with accurate measurement of fluid responsiveness.
- Renal Considerations: Patients undergoing renal replacement therapy or those with end-stage renal disease, as fluid balance and responsiveness may be altered.
- Pregnancy Hemodynamic changes during pregnancy (e.g., increased cardiac output and altered vascular resistance) differ significantly from septic shock.
- Patients with a body mass index (BMI) greater than 40 kg/m² Obesity can affect the accuracy of non-invasive monitoring techniques with poor window.
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 |
|---|---|---|
| CardiometryAlso: Inferior Vena Cava Ultrasound AssessmentBedside ultrasound measurement of inferior vena cava diameters during the respiratory cycle to calculate the collapsibility index at baseline and after fluid challenge | Procedure or surgery | Electrical Cardiometry Monitoring, Inferior Vena Cava Collapsibility Assessment Group |
Primary outcome
Septic Shock Evaluation
Time frame: Two Hours
Assessment of the participants which suffering from Septic Shock by using Inferior Vena Cava Collapsibility and Electrical Cardiometry for assisting the Fluid Responsiveness
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 13 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Septic Shock
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
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A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
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Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
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.
Noha Abdallah Afify, Professor study chair
Anaesthesia, Intensive Care and Pain Management, Faculty of Medicine, Menoufia 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 Menoufia 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Feb 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 Ahmed Mohamed Fared, MSc (+201005305140, ahmedm.fared9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Septic Shock Evaluation (time frame: Two Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2026.