Cardiometry versus IVC collapsibility to guide fluid decisions in septic shock

Comparison Between Using Cardiometry and IVC Collapsibility in Predicting Fluid Responsiveness in Hypovolemic Sepsis Patients

This study tests whether non-invasive cardiometry or ultrasound IVC collapsibility better predicts which patients with septic shock will respond to fluid treatment.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Menoufia University (Academic / other)
• Locations: 1 site (Shibīn al Kawm, Menoufia)
• Trial ID: NCT07411469 on ClinicalTrials.gov

What this trial studies

This observational study compares non-invasive electrical cardiometry measurements (stroke volume, cardiac output) with ultrasound-derived IVC collapsibility to predict fluid responsiveness in patients with septic shock. Participants meeting Sepsis-3 criteria with persistent hypotension after initial resuscitation will have paired cardiometry and IVC measurements recorded. Investigators will compare each method's ability to identify patients who clinically respond to fluid administration. The study is conducted at Menoufia University Hospital and includes adults with BMI 18.5–40 kg/m² and ASA physical status I–III.

Who should consider this trial

Good fit: Ideal candidates are adult patients with septic shock and persistent hypotension after initial resuscitation, with BMI 18.5–40 kg/m² and ASA physical status I–III.

Not a fit: Patients with extreme BMI (<18.5 or >40), ASA IV–V, or those already requiring invasive hemodynamic monitoring may not receive benefit from these non-invasive measures.

Why it matters

Potential benefit: If successful, this could help clinicians tailor fluid therapy more safely and reduce fluid overload and related complications in patients with septic shock.

How similar studies have performed: Previous studies of electrical cardiometry and IVC collapsibility have shown promising but mixed results, with some utility in predicting fluid responsiveness but limited validation in heterogeneous septic shock populations.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

\- 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.

Where this trial is running

Shibīn al Kawm, Menoufia

• Menoufia University Hospital — Shibīn al Kawm, Menoufia, Egypt (Recruiting)

Study contacts

• Study coordinator: Ahmed Mohamed Fared, MSc

Conditions Septic Shock