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NCT07792707
Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery
Conditions: Cardiac Surgical Procedures, Hemodynamics, Fluid Therapy, Acute Kidney Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Location: Montreal Heart Institute Montreal Quebec
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Adults aged ≥18 years
* Undergoing planned cardiac surgery with anticipated postoperative admission to the intensive care unit
* Pulmonary artery catheterization deemed clinically indicated by the treating anesthesiologist as part of routine perioperative care
Exclusion Criteria:
* Known stage 5 chronic kidney disease according to the KDIGO classification (eGFR less than 15 mL/min/1.73m2) or on renal replacement therapy
* Planned or ongoing mechanical circulatory support
* Planned or history of heart transplantation
Source: ClinicalTrials.gov (NCT07792707). StuddyBuddy aggregates publicly available trial information.