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UTF-in-CVICU
Using Structured Expert Consultation to Guide Fluid Optimization and Hemodynamic Recommendations After Cardiac surgEry: A Pilot Randomized Controlled Trial
Sponsor study identifier
interventional
75
1 country
2
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This multicenter pilot randomized controlled trial will evaluate whether providing treating physicians with a structured hemodynamic assessment influences care after cardiac surgery. The assessment combines point-of-care ultrasound, including the Venous Excess UltraSound (VExUS) score to assess fluid tolerance, with monitoring using the Swan-Ganz IQ catheter and HemoSphere Alta system to assess fluid responsiveness. Participants will be randomized to a structured hemodynamic assessment strategy or standard care. In the intervention group, treating physicians will receive a report of the structured assessment findings upon admission to the intensive care unit and on postoperative day 1. The co-primary objectives are to evaluate the impact of the structured assessment on treating physicians' management plans and to assess the feasibility of completing the study procedures and delivering assessment reports within the predefined time frame. Secondary and exploratory objectives include evaluating fluid balance, diuretic use, inotropic support, inhaled pulmonary vasodilator use, kidney function, and postoperative clinical outcomes. Exploratory analyses will also examine ultrasound measures of fluid responsiveness in relation to Swan-Ganz IQ measurements and the relationship between right ventricular pressure patterns and venous congestion.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 23, 2026
Actual (reported)August 28, 2026
Actual (reported)October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Feasibility of study procedures
Feasibility will be assessed as the proportion of participants for whom all study procedures are successfully completed, including completion of the structured hemodynamic assessment, communication of the report to the treating physician within two hours, and complete data collection. The study will be considered feasible if all study procedures are successfully completed in ≥80% of participants.
30 days after surgery
Clinical impact of the structured hemodynamic assessment on patient management
Impact of the structured hemodynamic assessment report on patient management in the intervention group, rated by the treating physician on a five-point scale.
Postoperative day 1
Participants will undergo a structured hemodynamic assessment combining point-of-care ultrasound to assess fluid tolerance using VExUS and Swan-Ganz IQ/HemoSphere Alta monitoring to assess fluid responsiveness during passive leg raising. An expert-reviewed report will be provided to the treating team within two hours of each assessment at ICU admission and on postoperative day 1. The report will include assessment findings, relevant contextual interpretation, and non-prescriptive therapeutic considerations. All treatment decisions will remain at the discretion of the treating team.
Participants will receive standard postoperative care. The same structured hemodynamic assessment will be performed, but findings will not be disclosed to the treating team unless disclosure is necessary to protect participant safety.
A structured hemodynamic assessment combining point-of-care ultrasound to assess fluid tolerance using the Venous Excess UltraSound (VExUS) score and Swan-Ganz IQ/HemoSphere Alta monitoring to assess fluid responsiveness during passive leg raising. Assessments are performed at ICU admission and on postoperative day 1. In the intervention group, an expert-reviewed report is provided to the treating team within two hours of each assessment, including findings, relevant contextual interpretation, and non-prescriptive therapeutic considerations. All treatment decisions remain at the discretion of the treating team.
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0C1, Canada
William Beaubien-Souligny, MD, PhD, FRCPC
CONTACT
First Submitted
August 23, 2026
First Posted
August 28, 2026
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Cumulative fluid balance
Up to 72 hours after randomization or ICU discharge, whichever occurs first
Cumulative loop diuretic dose
Up to 72 hours after randomization or ICU discharge, whichever occurs first
Number of diuretic agents used
Up to 72 hours after randomization or ICU discharge, whichever occurs first
Use of inotropic support
Up to 72 hours after randomization
Inotrope-free hours
Up to 72 hours after randomization
Duration of acute kidney injury
Up to postoperative day 7
Risk of transient acute kidney injury according to renal-splenic resistive index
Up to postoperative day 7
Physician-reported feedback on the point-of-care ultrasound assessment
Postoperative day 1
Standard postoperative fluid and hemodynamic management. Participants undergo the same structured hemodynamic assessment, but findings are not disclosed to the treating team unless necessary to protect participant safety.
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August 1, 2027
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 20, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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