Measuring how a 500 mL IV fluid bolus changes venous return to the heart
Official title: Assessment of Venous Return During Volume Expansion: a Prospective Observational Study
Run by Università Politecnica delle Marche · NCT07499388 · Data updated 2026-11-12
This test tries to see if giving 500 mL of crystalloid raises the pressure that drives blood back to the heart and increases cardiac output in critically ill ICU patients who need a fluid bolus.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Università Politecnica delle Marche Academic / other |
| Locations | 1 site (Ancona) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT07499388 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are critically ill ICU patients who have invasive or minimally invasive hemodynamic monitoring and a clinical indication for a 500 mL crystalloid bolus, and who do not meet exclusion criteria such as pregnancy or severe valvular disease.
✕Probably not a fit
Patients without hemodynamic monitoring, those with excluded conditions (pregnancy, severe aortic or mitral valve disease, peripheral arterial disease), or those who cannot be positioned supine are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study enrolls critically ill patients in the intensive care unit who have invasive or minimally invasive hemodynamic monitoring and a clinical indication for a 500 mL crystalloid volume expansion. Investigators will give a 500 mL crystalloid fluid challenge and measure changes in mean systemic filling pressure (Pms), central venous pressure (CVP), and the gradient between them to determine whether venous return—and therefore cardiac output—actually increases. The protocol excludes patients with conditions that reduce monitoring reliability (severe valvular disease, peripheral arterial disease), pregnancy, or contraindication to the supine position. The work is conducted at AOU delle Marche (Ancona) under the sponsorship of Università Politecnica delle Marche.
Why it matters
Potential benefit: If successful, this could help clinicians give fluids more precisely by identifying when a bolus will actually increase blood return and cardiac output, potentially avoiding unnecessary fluid overload.
How similar studies have gone: Prior research has widely studied fluid responsiveness using cardiac output changes, but applying Guyton-derived Pms measurements during a fluid bolus is relatively novel and has limited prior direct evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Critically ill patients admitted to the intensive care unit * Invasive or minimally invasive hemodynamic monitoring * Clinical indication for volume expansion with 500 mL of crystalloids Exclusion Criteria: * Suspected or confirmed pregnancy * Clinical conditions that may reduce the reliability of hemodynamic monitoring: * Severe aortic stenosis or regurgitation * Severe mitral stenosis or regurgitation * History of peripheral arterial disease * Clinical contraindications to the supine position
Where it's running
-
AOU delle Marche
Ancona, Italy Recruiting
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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.