Femoral vein-to-artery diameter ratio to predict fluid responsiveness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational study enrolling mechanically ventilated adult ICU patients with acute circulatory failure or shock who already have PiCCO monitoring and a clinician-planned fluid challenge. Baseline cardiac index will be recorded with PiCCO and femoral vein and artery diameters measured by bedside ultrasound, with each ultrasound repeated at least three times and averaged. A 500 mL balanced crystalloid will be given over 10 minutes and cardiac index remeasured, with fluid responsiveness defined as a >10% increase in cardiac index. The diagnostic performance of the femoral vein-to-artery diameter ratio will be compared to the PiCCO-derived change in cardiac index, and no additional invasive procedures will be performed for research purposes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients aged 18 years or older
* Admission to the intensive care unit where the study is being conducted
* Receiving invasive mechanical ventilation
* Clinical indication for a fluid challenge due to acute circulatory failure or shock, as determined by the responsible intensive care physician
* PiCCO monitoring already in place as part of routine clinical care
* Clinical conditions allowing collection of pre- and post-fluid challenge cardiac index and ultrasonographic measurements
* Technical feasibility of femoral vein and femoral artery diameter measurements by ultrasonography

Exclusion Criteria:

* Age younger than 18 years
* Failure to obtain written informed consent from the patient or legally authorized representative before enrollment
* Absence of PiCCO monitoring as part of routine clinical care or no clinical plan for fluid challenge
* Inability to complete pre- and post-fluid challenge measurements (e.g., early death, urgent surgery, transfer)
* Local conditions preventing reliable femoral ultrasonographic assessment, including open wound, infection, dressing, major anatomic obstacle, poor image quality, known femoral vein thrombosis, or severe vascular pathology on the relevant side
* Conditions likely to significantly impair the reliability of thermodilution measurements (e.g., severe tricuspid regurgitation or significant intracardiac shunt)
* Major treatment changes during the fluid challenge that preclude comparable measurements (e.g., major vasopressor dose change, major ventilator setting change, new arrhythmia)
* Missing or inadequate data judged by the investigators to compromise data integrity, including absence of measurements required for the primary outcome

Where it's running

• Istanbul University Cerrahpasa Medical Faculty
  Istanbul, Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: mert katılmış
• Email: mertkatilmis97@gmail.com
• Phone: +905346430560

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.