Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery

Study acronym: UTF-in-CVICU
StatusNot Yet Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 2 changed
Enrollment reduced 17% 90 → 75 participants
See other at-risk trials from Centre hospitalier de l'Université de Montréal (CHUM)

Record History

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  1. Notable Primary endpoint(s) modified Show 8 more changesShow less
    • Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM) to Centre hospitalier de l'Université de Montréal (CHUM)
    • Enrollment reduced: 90 → 75 participants
    • Interventions modified
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 3 of 16 entries
    • Study description expanded, about 201 words
    • Site details revised at 1 of 2 sites
    • Study title shortened, about 4 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07792707
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: Montreal Heart Institute
Conditions
(from sponsor)
Cardiac Surgical Procedures, Hemodynamics, Fluid Therapy, Acute Kidney Injury
Related terms Acute Kidney Injury, Hyperemia
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov