Ultrasound Evaluation for Cardiac Surgery
(UTF-in-CVICU Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults who have recently had heart surgery. It aims to include patients in the recovery period after their operation, but specific inclusion and exclusion criteria are not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Baseline Assessment
Baseline ultrasound examination performed before surgery
Postoperative Assessment
Structured hemodynamic assessment using point-of-care ultrasound and Swan-Ganz IQ monitoring upon ICU admission and on postoperative day 1
Follow-up
Participants are monitored for safety and effectiveness after treatment, including fluid balance, diuretic use, and kidney function
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two ways of managing fluids after heart surgery: one group gets ultrasound-guided fluid assessments, while the other receives standard care without extra ultrasound guidance. Patients are randomly assigned to each group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Montreal Heart Institute
Collaborator
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