Cardiometry versus IVC collapsibility to guide fluid decisions in septic shock
Official title: Comparison Between Using Cardiometry and IVC Collapsibility in Predicting Fluid Responsiveness in Hypovolemic Sepsis Patients
Run by Menoufia University · NCT07411469 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Menoufia University Academic / other |
| Locations | 1 site (Shibīn al Kawm, Menoufia) |
| Status | Recruiting |
| Started | May 10, 2025 |
| Main results expected | May 10, 2026 |
| Study ends | May 20, 2026 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT07411469 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Menoufia University Hospital
Shibīn al Kawm, Menoufia, Egypt Recruiting
Study contacts
- Study coordinator: Ahmed Mohamed Fared, MSc
- Email: ahmedm.fared9@gmail.com
- Phone: +201005305140
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.