Right Ventriculo-Arterial Coupling During Fluid Loading in ICU Patients

NCT07537621 | Not Yet Recruiting

• 1 other identifier: PL26041
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shock; Right Ventricular Dysfunction; Venous Congestion

Keywords

Right ventriculo-arterial coupling; Fluid loading; Venous congestion; VEXUS score; Critical care echocardiography

Outcome Measures

Primary Outcomes (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.

  Before a fluid loading procedure (approximately 30 min)

• 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.

  after a fluid loading procedure (approximately 30 min)

Secondary Outcomes (11)

• Variation of Right Ventriculo-Arterial Coupling According to Fluid Responsiveness

  Before a single fluid loading episode

• Variation of Right Ventriculo-Arterial Coupling According to Fluid Responsiveness

  after a single fluid loading episode

• Association Between Right Ventriculo-Arterial Coupling and Venous Congestion

  Before fluid loading

• Association Between Right Ventriculo-Arterial Coupling and Venous Congestion

  after fluid loading

• Predictors of Right Ventriculo-Arterial Coupling Deterioration

  before fluid loading

Study Arms (1)

Critically Ill Patients Receiving Fluid Loading

The study group consists of adult critically ill patients admitted to the intensive care unit who undergo fluid loading as part of routine clinical care, at the discretion of the attending physician. All patients are prospectively and consecutively included in a single observational cohort. Echocardiographic assessment of right ventricular function, right ventriculo-arterial coupling, and venous congestion parameters is performed before and after fluid administration. The group will be analyzed as a whole, with secondary analyses stratifying patients according to fluid responsiveness or presence of venous congestion. This cohort reflects standard clinical practice in critically ill patients with acute circulatory failure.

Other: Echography

Interventions

Echography OTHER

Fluid 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.

Critically Ill Patients Receiving Fluid Loading

Eligibility Criteria

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

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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)
• Ongoing acute coronary syndrome
• Acute or pulmonale (defined by right ventricular dilation associated with paradoxical septal motion related to an abrupt increase in right ventricular afterload)
• Primary pulmonary arterial hypertension
• Intra-abdominal hypertension (intravesical pressure \> 15 mmHg)
• Poor echogenicity precluding adequate echocardiographic assessment of the right ventricle
• Severe valvular heart disease or early postoperative period following valvular surgery

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Marie Muller

Reims, France

Location

MeSH Terms

Conditions

Shock; Ventricular Dysfunction, Right; Hyperemia

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Central Study Contacts

Morgan CAPLAN

CONTACT

03 10 73 60 22; mcaplan@chu-reims.fr

Guillaume THERY

CONTACT

gthery@chu-reims.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

FR (1)