Right Ventriculo-Arterial Coupling During Fluid Loading in ICU Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCHU de Reims
About this trial
Preload responsiveness and venous congestion have largely been investigated independently in recent literature. However, recent data report a similar incidence of venous congestion regardless of fluid responsiveness status, challenging the concept of a linear continuum between preload independence and fluid intolerance. These findings support the need for a more individualized hemodynamic management strategy that takes venous congestion risk into account.
The right ventricle plays a central role in this framework. Its function is to maintain an adequate venous return pressure gradient to ensure cardiac output while limiting upstream venous congestion, under strong dependence on its afterload. In physiological conditions, the right ventricle adapts to changes in afterload by increasing contractility to preserve right ventriculo-arterial coupling and optimize its performance.
In chronic cardiopulmonary diseases, right ventriculo-arterial uncoupling is a well-established prognostic factor, including the presence of occult uncoupling revealed by fluid loading. In critically ill patients, right ventricular systolic dysfunction associated with venous congestion-defining right heart failure-is strongly associated with increased mortality, as is right ventriculo-arterial uncoupling itself.
To support the concept of fluid tolerance, the investigators hypothesize that impairment of right ventriculo-arterial coupling may exist or occur during fluid loading in critically ill patients, independently of preload responsiveness, and may be associated with worsening upstream venous congestion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Critically ill hospitalized patients
Age ≥ 18 years
Patients undergoing fluid loading at the discretion of the attending physician, following prediction of fluid responsiveness using any recommended maneuver or dynamic parameter, in the setting of acute circulatory failure requiring vasopressor support and/or mean arterial pressure < 65 mmHg (or a decrease of ≥ 30 mmHg from baseline in patients with chronic hypertension), and/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia)
Affiliated with a national health insurance system
Disqualifiers
Formal refusal from the patient or legally representative after information
Patients transferred from another intensive care unit
Pregnant or postpartum patients
Acute respiratory distress (defined as respiratory rate ≥ 35 breaths/min and/or signs of increased work of breathing)
Trial population
The study population consists of adult critically ill patients with acute circulatory failure. Eligible patients are those for whom the attending physician independently decides to perform fluid loading as part of standard care, in accordance with current European recommendations. Patients may present with hypotension requiring vasopressor support, low mean arterial pressure, or other signs of hemodynamic instability. Participants are prospectively and consecutively included at the time of fluid loading decision, and undergo standardized echocardiographic assessment of right ventricular function and venous congestion before and after fluid administration. The population reflects routine clinical practice in the intensive care unit.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Echography
Other interventionFluid loading administered according to standard clinical practice at the discretion of the treating physician. Echocardiographic assessment of right ventricular function and venous congestion is performed before and after fluid administration. No experimental treatment is applied.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Critically Ill Patients Receiving Fluid Loading1 intervention
Trial outcomes
Primary outcomes
1
Right Ventriculo-Arterial Coupling Changes During Fluid Loading
Echocardiographic assessment of right ventriculo-arterial coupling will be performed using the TAPSE/TRV ratio before and after fluid loading. The primary outcome is the change in TAPSE/TRV, reflecting alterations in right ventricular contractility and coupling with the pulmonary circulation in response to fluid administration. This outcome will be used to evaluate the prevalence and dynamics of RV uncoupling in critically ill patients.
Time frame
Before a fluid loading procedure (approximately 30 min)2
Right Ventriculo-Arterial Coupling Changes During Fluid Loading
Echocardiographic assessment of right ventriculo-arterial coupling will be performed using the TAPSE/TRV ratio before and after fluid loading. The primary outcome is the change in TAPSE/TRV, reflecting alterations in right ventricular contractility and coupling with the pulmonary circulation in response to fluid administration. This outcome will be used to evaluate the prevalence and dynamics of RV uncoupling in critically ill patients.
Time frame
after a fluid loading procedure (approximately 30 min)Secondary outcomes
1
Variation of Right Ventriculo-Arterial Coupling According to Fluid Responsiveness
Changes in right ventriculo-arterial coupling (TAPSE/TRV ratio) will be compared between fluid responders (RV+) and non-responders (RV-) to assess the influence of fluid responsiveness on coupling dynamics.
Time frame
Before a single fluid loading episode2
Variation of Right Ventriculo-Arterial Coupling According to Fluid Responsiveness
Changes in right ventriculo-arterial coupling (TAPSE/TRV ratio) will be compared between fluid responders (RV+) and non-responders (RV-) to assess the influence of fluid responsiveness on coupling dynamics.
Time frame
after a single fluid loading episode3
Association Between Right Ventriculo-Arterial Coupling and Venous Congestion
The relationship between TAPSE/TRV ratio and upstream venous congestion parameters, including VExUS score and portal vein pulsatility, will be evaluated to determine the impact of right ventricular uncoupling on venous congestion.
Time frame
Before fluid loading4
Association Between Right Ventriculo-Arterial Coupling and Venous Congestion
The relationship between TAPSE/TRV ratio and upstream venous congestion parameters, including VExUS score and portal vein pulsatility, will be evaluated to determine the impact of right ventricular uncoupling on venous congestion.
Time frame
after fluid loadingSponsors and contacts
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Source ClinicalTrials.gov