Prospective Observational Study of Right Ventriculo-arterial Coupling Changes During Fluid Loading and Their Relationship With Congestion Parameters in Critically Ill Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHU de Reims
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Right Ventriculo-Arterial Coupling Changes During Fluid Loading
研究概览
简要总结
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.
详细描述
This is a prospective observational study designed to evaluate right ventriculo-arterial coupling dynamics during fluid loading in critically ill patients with acute circulatory failure. The study aims to characterize alterations in coupling, their relationship with venous congestion, and the performance of different echocardiographic indices used to quantify right ventricular function and coupling.
Study Population:
Critically ill adult patient in intensive care unit who require fluid loading as part of routine clinical management, based on the attending physician's discretion. Eligible patients may present with hypotension requiring vasopressor support, low mean arterial pressure, or other signs of hemodynamic instability. Patients are prospectively and consecutively included, reflecting standard ICU practice.
Study Procedures:
Fluid loading is administered according to current clinical guidelines. Echocardiographic assessment of the right ventricle is performed immediately before and after fluid administration. The primary measure of RVPA is the TAPSE/TRV ratio. Additional echocardiographic parameters will be collected and other validated indices to define RVPA to allow comparisons across methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Echography (Other)
结局指标
主要结局
Right Ventriculo-Arterial Coupling Changes During Fluid Loading
时间窗: Before a fluid loading procedure (approximately 30 min)
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.
Right Ventriculo-Arterial Coupling Changes During Fluid Loading
时间窗: after a fluid loading procedure (approximately 30 min)
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.
次要结局
- 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)
- Comparison of Echocardiographic Parameters Across Groups(before fluid loading)
- Comparison of Echocardiographic Parameters Across Groups(after fluid loading)
- Comparison of Echocardiographic Parameters Characterizing Right Ventriculo-Arterial Coupling(before fluid loading)
- TAPSE/PASP Ratio as a Marker of Right Ventriculo-Arterial Coupling Coupling(after fluid loading)
- Tricuspid S-wave Velocity/PASP Ratio as a Marker of Right Ventriculo-Arterial Coupling(After fluid loading)
- Agreement Between Echocardiographic Indices of Right Ventriculo-Arterial Coupling(After fluid loading)