This pilot randomized controlled trial will evaluate the use of point-of-care ultrasound (POCUS) to assess fluid tolerance and fluid responsiveness in patients following cardiac surgery. Participants will be randomized to an ultrasound-guided assessment strategy or standard care. In the intervention group, treating physicians will receive the results of a structured ultrasound assessment, including the Venous Excess UltraSound (VExUS) score and an assessment of fluid responsiveness.
The primary objectives are to determine whether this information influences clinical management and to assess the feasibility of the study procedures. The study will also explore differences in fluid and hemodynamic management, kidney function, and postoperative clinical outcomes.
Adults aged ≥18 years
Undergoing planned cardiac surgery with anticipated postoperative admission to the intensive care unit
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
Parallel
Structured Point-of-Care Ultrasound Assessment
Diagnostic testA structured point-of-care ultrasound assessment combining evaluation of fluid tolerance using the Venous Excess UltraSound (VExUS) score and assessment of fluid responsiveness. Results are communicated to the treating physician to support postoperative fluid and hemodynamic management.
Standard Care (in control arm)
Other interventionParticipants will receive standard postoperative fluid and hemodynamic management. Study-specific point-of-care ultrasound assessment results will not be communicated to the treating physician.
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 ultrasound examination, communication of the ultrasound 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.
Clinical impact of the POCUS assessment on patient management
Proportion of participants in the intervention group for whom the treating physician reports that the POCUS assessment resulted in a change in the clinical management.
Cumulative fluid balance
Cumulative fluid balance, measured in milliliters (mL), from randomization until 72 hours after randomization or ICU discharge, whichever occurs first.
Cumulative loop diuretic dose
Cumulative dose of loop diuretic medication, measured in milligrams (mg), from randomization until 72 hours after randomization or ICU discharge, whichever occurs first.
Number of diuretic agents used
Number of diuretic agents used (0, 1, or 2). Two agents indicate combination diuretic therapy with a loop diuretic and a thiazide diuretic.
Use of inotropic support
Proportion of participants receiving inotropic medication following randomization
Duration of acute kidney injury
Acute kidney injury (AKI) will be classified as transient or persistent according to its duration. Transient AKI is defined as resolution within 48 hours, while persistent AKI is defined as persistence beyond 48 hours.
Risk of transient acute kidney injury according to renal-splenic resistive index
Renal-splenic resistive index will be calculated as the difference between the mean renal resistive index (RRI) and mean splenic resistive index (SRI), both measured using pulsed-wave Doppler ultrasound. Logistic regression will be used to evaluate the relationship between renal-splenic resistive index and transient acute kidney injury (yes/no).
Physician-reported feedback on the point-of-care ultrasound assessment
Qualitative assessment of treating physicians' comments regarding the usefulness of the point-of-care ultrasound assessment and its influence on clinical decision-making.
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Montreal Heart Institute
Collaborator
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