An interventional study of Expert Report of a Structured Hemodynamic Assessment and Standard Care (in control arm) in Cardiac Surgical Procedures, Hemodynamics and Fluid Therapy, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Not yet recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
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.
Postoperative management following cardiac surgery requires the integration of clinical and hemodynamic variables to guide individualized treatment. Important decisions include fluid balance management, the use of vasoactive medications, inotropic support, pulmonary vasodilators, and more. Combining point-of-care ultrasound (POCUS) and advanced hemodynamic monitoring may provide complementary information by assessing fluid tolerance, fluid responsiveness, and potential mechanisms underlying hemodynamic abnormalities.
Fluid tolerance refers to the ability to receive additional fluid without developing or worsening clinically significant congestion. The Venous Excess UltraSound (VExUS) score evaluates systemic venous congestion using inferior vena cava diameter and hepatic, portal, and intrarenal venous Doppler. Abnormal VExUS findings have been associated with adverse outcomes following cardiac surgery; however, whether incorporating this information into a structured decision-support strategy influences clinical management remains uncertain.
Fluid responsiveness refers to the capacity of cardiac output to increase following an increase in cardiac preload. In this study, it will be assessed using continuous estimated cardiac output (eCO) obtained with the Swan-Ganz IQ catheter and HemoSphere Alta monitor during a passive leg raise (PLR) maneuver. Fluid responsiveness will be defined as an increase in eCO of at least 10%, with return to baseline after the maneuver. Combining fluid tolerance and fluid responsiveness assessments may help identify patients who could benefit from fluid administration while identifying those at risk of adverse effects from fluid accumulation.
USE-the-FORCE-in-CVICU is a multicenter pilot randomized controlled trial enrolling 75 adult cardiac surgery patients at the Centre hospitalier de l'Université de Montréal and the Montreal Heart Institute. Participants will be randomized in a 2:1 ratio to a structured hemodynamic assessment strategy or standard care. A baseline ultrasound examination will be performed before surgery, followed by ultrasound and hemodynamic assessments in both groups upon intensive care unit (ICU) admission and on postoperative day 1.
In the intervention group, an expert will provide a structured report of the assessment to the treating team within two hours of each postoperative assessment. The report will describe fluid tolerance and fluid responsiveness, contextual interpretation of relevant findings, and individualized therapeutic considerations. Recommendations will be non-prescriptive, and all treatment decisions will remain at the discretion of the treating team. In control participants, the structured hemodynamic assessment will also be performed, but the findings will not be disclosed to the treating team unless disclosure is necessary to protect participant safety. Control participants will receive standard postoperative care. Participants and outcome assessors will be blinded to allocation; treating clinicians cannot be blinded to receipt of the reports.
The trial has two co-primary objectives. The proof-of-concept objective is to evaluate the impact of the additional hemodynamic information on clinical management using a physician-reported five-point usefulness scale. The feasibility objective is to determine whether all required study procedures can be completed in more than 80% of participants, including planned assessments, timely report transmission in the intervention group, and outcome data collection.
Secondary outcomes will include fluid balance and diuretic use during the first 72 hours after randomization or until ICU discharge, whichever occurs first, and inotropic support and inhaled pulmonary vasodilator use during the first 72 hours. Kidney outcomes will include acute kidney injury incidence and severity using serum creatinine-based KDIGO criteria, kinetic estimated glomerular filtration rate during the first seven days after randomization, and classification of acute kidney injury as transient or persistent.
Additional outcomes will include time alive and free of vasopressors, mechanical ventilation, ICU care, or hospitalization; kidney replacement therapy; and cumulative time with perioperative organ dysfunction or death through postoperative day 28. Operative mortality will include deaths during the surgical hospitalization and deaths after discharge within 30 postoperative days. Qualitative feedback will explore physicians' perspectives on the assessment's influence on management and barriers to acting on the findings.
Exploratory analyses will compare PLR-induced changes in corrected carotid flow time with simultaneous changes in Swan-Ganz IQ-derived eCO, describe right ventricular pressure waveform patterns and their relationship with VExUS grade, and examine renal and splenic arterial Doppler indices in relation to acute kidney injury subtypes.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 75 is below the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
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The criteria were revised on the registry on Oct 20, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Expert Report of a Structured Hemodynamic Assessment
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.
Other: Standard Care (in control arm)
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.
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.
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.
Time frame: 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.
Time frame: Postoperative day 1
Cumulative fluid balance
Cumulative fluid balance, measured in milliliters (mL), from randomization until 72 hours after randomization or ICU discharge, whichever occurs first.
Time frame: Up to 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.
Time frame: Up to 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.
Time frame: Up to 72 hours after randomization or ICU discharge, whichever occurs first
Use of inotropic support
Proportion of participants receiving inotropic medication following randomization
Time frame: Up to 72 hours after randomization
Inotrope-free hours
Number of hours alive and free from inotropic support following randomization
Time frame: Up to 72 hours after randomization
Use of inhaled pulmonary vasodilators
Proportion of participants receiving inhaled pulmonary vasodilator therapy, including inhaled epoprostenol, inhaled milrinone, or inhaled nitric oxide
Time frame: Up to 72 hours after randomization
Incidence of acute kidney injury
Proportion of participants developing acute kidney injury (AKI), defined according to KDIGO serum creatinine criteria. Urine output criteria will not be used. AKI is defined as an increase in serum creatinine ≥26.5 µmol/L within 48 hours or an increase to ≥1.5 times baseline within 7 days.
Time frame: Up to postoperative day 7
Severity of acute kidney injury
Severity of acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) staging system, ranging from stage 1 to stage 3, based on serum creatinine criteria. Renal replacement therapy is classified as stage 3. Higher stages indicate greater severity of acute kidney injury.
Time frame: Up to postoperative day 7
Kinetic estimated glomerular filtration rate (KeGFR)
Kinetic estimated glomerular filtration rate (KeGFR), derived from serial serum creatinine measurements using the kinetic GFR equation.
Time frame: Up to postoperative day 7
Initiation of renal replacement therapy
Proportion of participants requiring initiation of renal replacement therapy.
Time frame: Up to postoperative day 28
Vasopressor-free hours
Number of hours alive and free from vasopressor therapy.
Time frame: Up to postoperative day 28
Ventilator-free hours
Number of hours alive and free from mechanical ventilation.
Time frame: Up to postoperative day 28
ICU-free days
Number of days alive and outside the intensive care unit (ICU).
Time frame: Up to postoperative day 28
Hospital-free days
Number of days alive and outside the hospital.
Time frame: Up to postoperative day 28
Operative mortality
Proportion of participants who die during the hospitalization in which the operation was performed, regardless of timing, or following hospital discharge but within 30 postoperative days.
Time frame: During the index hospitalization or up to 30 days after surgery following discharge
Cumulative time in perioperative organ dysfunction (TPOD)
Cumulative duration, in hours, of mechanical ventilation, vasopressor therapy, renal replacement therapy, and mechanical circulatory support.
Time frame: Up to postoperative day 28
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.
Time frame: Up to postoperative day 7
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).
Time frame: Up to postoperative day 7
Physician-reported feedback on the point-of-care ultrasound assessment
Qualitative assessment of treating physicians' comments regarding the usefulness of the hemodynamic assessment and its influence on clinical decision-making.
Time frame: Postoperative day 1
Correlation Between Changes in Corrected Carotid Flow Time and Estimated Cardiac Output During Passive Leg Raising
Pearson or Spearman correlation, as appropriate, between the absolute change in corrected carotid flow time (milliseconds) and the simultaneous percentage change in Swan-Ganz IQ/HemoSphere Alta-derived estimated cardiac output during passive leg raising.
Time frame: ICU admission and postoperative day 1
Distribution of VExUS Grades by Right Ventricular Pressure Waveform Category
Number and percentage of assessments in each Venous Excess UltraSound (VExUS) grade within each prespecified right ventricular pressure waveform category. Differences in the distribution of VExUS grades across waveform categories will be evaluated using categorical or ordinal statistical methods, accounting for repeated assessments within participants where appropriate. VExUS grades range from 0 to 3, with higher grades indicating greater venous congestion.
Time frame: ICU admission and postoperative day 1
Plan to share: Undecided
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