Prediction of Fluid Responsiveness Using the Femoral Vein-to-Artery Diameter Ratio
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa
About this trial
This prospective single-center observational study aims to evaluate whether the ultrasound-measured femoral vein-to-femoral artery diameter ratio can predict fluid responsiveness in mechanically ventilated adult intensive care patients with acute circulatory failure or shock. Only patients who already have PiCCO monitoring as part of routine clinical care and for whom a fluid challenge is clinically indicated will be included. No additional invasive procedure will be performed for study purposes. Cardiac index will be measured with PiCCO before and after administration of 500 mL balanced crystalloid over 10 minutes, and femoral vein and femoral artery diameters will be measured by bedside ultrasonography. Fluid responsiveness will be defined as an increase of more than 10% in cardiac index after fluid administration. The study will assess the diagnostic performance of the femoral vein-to-femoral artery diameter ratio as a practical bedside parameter to support hemodynamic decision-making in critically ill patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
The study population consists of adult intensive care unit patients with acute circulatory failure or shock who are receiving invasive mechanical ventilation and for whom the responsible intensive care physician has determined a clinical indication for a fluid challenge. Only patients who already have PiCCO monitoring in place as part of routine clinical care and in whom femoral vein and femoral artery ultrasonographic measurements can be obtained will be enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ultrasound Measurement of Femoral Vein-to-Femoral Artery Diameter Ratio
Diagnostic testBedside ultrasonographic measurement of femoral vein and femoral artery diameters at the same anatomical level proximal to the femoral artery bifurcation, with at least three repeated measurements and calculation of the femoral vein-to-femoral artery diameter ratio before and after a clinically indicated fluid challenge.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Diagnostic performance of the baseline femoral vein-to-femoral artery diameter ratio for predicting fluid responsiveness
Diagnostic performance of the baseline ultrasound-measured femoral vein-to-femoral artery diameter ratio in identifying fluid responders, assessed by receiver operating characteristic analysis (area under the curve). Fluid responsiveness will be defined as an increase of more than 10% in cardiac index after administration of 500 mL balanced crystalloid over 10 minutes.
Time frame
Baseline assessment before fluid challenge, with responder status determined 10 minutes after completion of the fluid challengeSecondary outcomes
1
Percent change in cardiac index after fluid challenge
Percent change in PiCCO-derived cardiac index after administration of 500 mL balanced crystalloid over 10 minutes.
Time frame
Before fluid challenge and 10 minutes after completion of the fluid challengeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov