Ultrasound Evaluation of Fluid Tolerance and Fluid Responsiveness in Postoperative Cardiac Surgery Patients

NCT07792707 | Not Yet Recruiting

• 1 other identifier: MP-02-2026-13298
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiac Surgical Procedures; Hemodynamics; Fluid Therapy; Acute Kidney Injury

Keywords

Venous Congestion; Venous Excess UltraSound (VExUS); Fluid Responsiveness; Fluid Tolerance; Point-of-Care Ultrasound; Hemodynamic Management

Outcome Measures

Primary Outcomes (2)

• 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.

  30 days after surgery

• 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.

  Postoperative day 1

Secondary Outcomes (16)

• 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

Other Outcomes (3)

• 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

Study Arms (2)

POCUS-Guided assessment

EXPERIMENTAL

Participants will undergo a structured point-of-care ultrasound assessment of fluid tolerance and fluid responsiveness. The results will be communicated to the treating physician to support fluid and hemodynamic management. Therapeutic decisions will remain at the discretion of the treating physician.

Diagnostic Test: Structured Point-of-Care Ultrasound Assessment

Standard Care

ACTIVE COMPARATOR

Participants will receive standard postoperative care. The results of the study-specific point-of-care ultrasound assessment will not be communicated to the treating physician.

Other: Standard Care (in control arm)

Interventions

Structured Point-of-Care Ultrasound Assessment DIAGNOSTIC_TEST

A 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.

POCUS-Guided assessment

Standard Care (in control arm) OTHER

Participants will receive standard postoperative fluid and hemodynamic management. Study-specific point-of-care ultrasound assessment results will not be communicated to the treating physician.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years
• Undergoing planned cardiac surgery with anticipated postoperative admission to the intensive care unit

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Montreal Heart Institute: collaborator

Study Sites (2)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

Location

MeSH Terms

Conditions

Acute Kidney Injury; Hyperemia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

William Beaubien-Souligny, MD, PhD, FRCPC

CONTACT

514-890-8000; william.beaubien-souligny.med@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

CA (2)