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Clinical Trial NCT07499388 (PSM-PVC-RITVEN) for Hemodynamic Changes is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Assessment of Venous Return During Volume Expansion: a Prospective Observational Study (PSM-PVC-RITVEN) 45 Observational
Clinical Trial NCT07499388 (PSM-PVC-RITVEN) is an observational study for Hemodynamic Changes that is recruiting. It started on March 1, 2025 with plans to enroll 45 participants. Led by Università Politecnica delle Marche, it is expected to complete by July 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary
According to Guyton's model of venous return, the fluids that effectively increase cardiac output are those that, once administered, increase the vascular stressed volume, thereby increasing the mean systemic filling pressure (Pms) without increasing the central venous pressure (CVP). In this way, since the gradient between Pms and CVP increases, venous return-and consequently cardiac output-also increases.
In cases...
Show MoreOfficial Title
Assessment of Venous Return During Volume Expansion: a Prospective Observational Study
Conditions
Hemodynamic ChangesOther Study IDs
- PSM-PVC-RITVEN
- PSM-PVC-VENRET
NCT ID Number
Start Date (Actual)
2025-03-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-07
Enrollment (Estimated)
45
Study Type
Observational
Status
Recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
N/A | Fluid challenge of 500ml of crystalloid The mean systemic filling pressure (Pms) will be measured using the transient stop-flow arm technique, a method routinely used in clinical practice. This involves placing a non-invasive blood pressure cuff on the same arm where invasive arterial pressure is monitored via the radial artery. The cuff is inflated for one minute to temporarily occlude blood flow. At the end of this period, the invasive arterial pressure ...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Variation of the Venous Return Gradient (Pms - CVP) in Fluid Responders | To describe the change in the venous return gradient (mean systemic filling pressure minus central venous pressure, Pms - CVP) during volume expansion with 500 mL of crystalloids in fluid responsive patients.
The fluid challenge is administered according to the clinician's indication. A total of 500 mL of crystalloids is infused over 25 minutes, corresponding to an infusion rate of 1200 mL/h. | Measurements are taken at baseline, and at 7 minutes and 30 seconds, 12 minutes and 30 seconds, and 25 minutes from the start of crystalloid infusion (corresponding to 150 mL, 250 mL, and 500 mL infused, respectively). |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Venous Return Gradient Variation in Fluid Responders vs Non-Responders | To compare the change in Pms - CVP between fluid responders and non-responders during volume expansion with 500 mL of crystalloids. The fluid challenge is administered according to the clinician's indication. A total of 500 mL of crystalloids is infused over 25 minutes, corresponding to an infusion rate of 1200 mL/h. | Measurements are taken at baseline, and at 7 minutes and 30 seconds, 12 minutes and 30 seconds, and 25 minutes from the start of crystalloid infusion (corresponding to 150 mL, 250 mL, and 500 mL infused, respectively). |
Venous Return Gradient Variation in the General Population | To describe the changes in Pms - CVP in the overall study population during volume expansion with 500 mL of crystalloids in fluid responsive patients. The fluid challenge is administered according to the clinician's indication. A total of 500 mL of crystalloids is infused over 25 minutes, corresponding to an infusion rate of 1200 mL/h. | Measurements are taken at baseline, and at 7 minutes and 30 seconds, 12 minutes and 30 seconds, and 25 minutes from the start of crystalloid infusion (corresponding to 150 mL, 250 mL, and 500 mL infused, respectively). |
Cardiac Index Variation in the General Population | To assess changes in cardiac index in the overall study population during volume expansion with 500 mL of crystalloids. The fluid challenge is administered according to the clinician's indication. A total of 500 mL of crystalloids is infused over 25 minutes, corresponding to an infusion rate of 1200 mL/h. | Measurements are taken at baseline, and at 7 minutes and 30 seconds, 12 minutes and 30 seconds, and 25 minutes from the start of crystalloid infusion (corresponding to 150 mL, 250 mL, and 500 mL infused, respectively). |
Mean Systemic Filling Pressure (Pms) Variation in the General Population | To evaluate how Pms changes in the overall population during volume expansion with 500 mL of crystalloids. The fluid challenge is administered according to the clinician's indication. A total of 500 mL of crystalloids is infused over 25 minutes, corresponding to an infusion rate of 1200 mL/h. | Measurements are taken at baseline, and at 7 minutes and 30 seconds, 12 minutes and 30 seconds, and 25 minutes from the start of crystalloid infusion (corresponding to 150 mL, 250 mL, and 500 mL infused, respectively). |
Central Venous Pressure (CVP) Variation in the General Population | To describe how CVP varies in the overall population during volume expansion with 500 mL of crystalloids. The fluid challenge is administered according to the clinician's indication. A total of 500 mL of crystalloids is infused over 25 minutes, corresponding to an infusion rate of 1200 mL/h. | Measurements are taken at baseline, and at 7 minutes and 30 seconds, 12 minutes and 30 seconds, and 25 minutes from the start of crystalloid infusion (corresponding to 150 mL, 250 mL, and 500 mL infused, respectively). |
Cardiac Index Variation in Fluid Responders vs Non-Responders | To compare cardiac index changes between fluid responders and non-responders during volume expansion with 500 mL of crystalloids. The fluid challenge is administered according to the clinician's indication. A total of 500 mL of crystalloids is infused over 25 minutes, corresponding to an infusion rate of 1200 mL/h. | Measurements are taken at baseline, and at 7 minutes and 30 seconds, 12 minutes and 30 seconds, and 25 minutes from the start of crystalloid infusion (corresponding to 150 mL, 250 mL, and 500 mL infused, respectively). |
Mean Systemic Filling Pressure (Pms) Variation in Fluid Responders vs Non-Responders | To compare Pms changes between fluid responders and non-responders during volume expansion with 500 mL of crystalloids. The fluid challenge is administered according to the clinician's indication. A total of 500 mL of crystalloids is infused over 25 minutes, corresponding to an infusion rate of 1200 mL/h. | Measurements are taken at baseline, and at 7 minutes and 30 seconds, 12 minutes and 30 seconds, and 25 minutes from the start of crystalloid infusion (corresponding to 150 mL, 250 mL, and 500 mL infused, respectively). |
Central Venous Pressure (CVP) Variation in Fluid Responders vs Non-Responders | To evaluate CVP changes in fluid responders compared to non-responders during volume expansion with 500 mL of crystalloids. The fluid challenge is administered according to the clinician's indication. A total of 500 mL of crystalloids is infused over 25 minutes, corresponding to an infusion rate of 1200 mL/h. | Measurements are taken at baseline, and at 7 minutes and 30 seconds, 12 minutes and 30 seconds, and 25 minutes from the start of crystalloid infusion (corresponding to 150 mL, 250 mL, and 500 mL infused, respectively). |
Systemic Vascular Resistance (SVR) Variation in Fluid Responders vs Non-Responders | To describe and compare changes in systemic vascular resistance between fluid responders and non-responders during volume expansion with 500 mL of crystalloids. The fluid challenge is administered according to the clinician's indication. A total of 500 mL of crystalloids is infused over 25 minutes, corresponding to an infusion rate of 1200 mL/h. | Measurements are taken at baseline, and at 7 minutes and 30 seconds, 12 minutes and 30 seconds, and 25 minutes from the start of crystalloid infusion (corresponding to 150 mL, 250 mL, and 500 mL infused, respectively). |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Università Politecnica delle MarcheStudy Responsible Party
Abele Donati, MD, Principal Investigator, MD, PhD, Full Professor, Head of ICU, Università Politecnica delle Marche
No contact data.
1 Study Locations in 1 Countries
AOU delle Marche, Ancona, 60123, Italy
Abele Pr Donati, PhD, Contact, 0715963858, [email protected]
Recruiting