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临床试验/NCT07730242
NCT07730242尚未招募不适用

BEAT- FR Beat-to-beat Evaluation of Atrial Pacing to Test Fluid Responsiveness

Maastricht University Medical Center0 个研究点目标入组 18 人开始时间: 2027年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
18
主要终点
change in stroke volume measured before and after fluid administration in response to beat-to-beat atrial pacing.

研究概览

简要总结

The goal of this observational study is to learn whether atrial pacing-induced preload variation can identify fluid responsiveness in adult patients admitted to the intensive care unit after cardiac surgery.

The main questions it aims to answer are:

Can beat-to-beat atrial pacing induce measurable changes in stroke volume that predict fluid responsiveness? Do stroke volume changes measured by transthoracic echocardiography (LVOT VTI) and arterial waveform analysis identify patients who respond to a 500 mL fluid bolus?

Researchers will compare fluid responders and non-responders, defined by a ≥10% increase in stroke volume after a 500 mL Ringer's lactate fluid bolus, to determine whether pacing-induced hemodynamic changes predict fluid responsiveness.

Participants will:

Undergo a standardized atrial pacing protocol (80-120 bpm in 10 bpm increments) before and after a routine 500 mL Ringer's lactate fluid bolus.

Undergo transthoracic echocardiography and continuous arterial pressure monitoring during the pacing protocol.

Have routine ICU hemodynamic data collected during their admission.

详细描述

INTRODUCTION AND RATIONALE Fluid administration is still the cornerstone in the treatment of hemodynamically unstable patients to enhance oxygen delivery and ensure adequate tissue perfusion. The intended effect is an increase in cardiac output by increasing preload.

However, the effectiveness of fluid therapy depends heavily on the patient's fluid responsiveness, defined as the ability of the heart to increase stroke volume in response to a fluid challenge [1]. Despite its central role in intensive care, fluid management remains a challenge, with both under- and over-resuscitation posing risks to patient outcomes [2,3].

Excessive fluid resuscitation, commonly referred to as "fluid overload," has been linked to adverse outcomes, including increased risk of organ dysfunction, prolonged mechanical ventilation, and higher mortality rates [4,5]. On the other hand, insufficient fluid administration can exacerbate hypoperfusion and organ failure [6]. The need for accurate and timely assessment of fluid responsiveness has therefore become a priority in optimizing care for critically ill patients [7].

Challenges in current methods for fluid responsiveness assessment Current methods for evaluating fluid status have limitations concerning their invasiveness, applicability, and sensitivity and specificity. For example, static preload indicators such as central venous pressure (CVP) and pulmonary capillary wedge pressure (PCWP) have failed to reliably predict fluid responsiveness [8]. Dynamic variables such as pulse pressure variation (PPV) offer improved accuracy, but their predictive value is restricted to specific conditions [9], limiting their broader applicability [10]. Moreover, techniques like passive leg raising (PLR), though effective, are non-continuous, technically challenging, and require real-time stroke volume monitoring [11]. Premature ventricular complexes and preload variation From observational studies, preclinical data and modelling, the physiological concept of acutely varying preload and measuring the heart's contractile response has potential for assessing fluid status and predicting fluid responsiveness. A premature ventricular complex (PVC) causes such an acute preload change by causing a compensatory pause and increasing preload. Proof-of-concept studies in cardiac surgery patients [12] and critically ill populations [13] have demonstrated the potential of PVCs in predicting fluid responsiveness. However, since extrasystoles do not consistently occur in all patients, their usefulness for standardized fluid responsiveness evaluation is limited.

This limitation has led to interest in controlled methods for inducing acute preload variations. Advances in cardiac pacing technology have made it possible to manipulate heart rate and RR-intervals in a controlled manner, offering a potential solution.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or older.
  • Underwent CABG surgery, without concomitant valve surgery.
  • Admitted to the ICU during the first postoperative day.
  • Equipped with surgically placed temporary atrial pacemaker wire.
  • Scheduled for a 500 mL bolus of balanced solution (Ringer's lactate) within the first two postoperative hours for clinical reasons.
  • Able to provide preoperative consent at the outpatient clinic before the surgery takes place.
  • Assessed by the attending intensivist as hemodynamically stable and (thereby) eligible for the study.

排除标准

  • Presence of atrial fibrillation or other arrhythmias precluding atrial pacing.
  • Absence of atrial pacemaker wire.
  • Suspected cardiac tamponade or significant postoperative bleeding (e.g., >400 mL blood loss in the first hour postoperatively).
  • Use of extracorporeal life support (ECLS) during the observation period.
  • Acute changes in vasopressor or inotrope dosage within the observation period.
  • Significant changes in body position, ventilator settings, or pacing mode during the study protocol.
  • Known contraindications to echocardiographic monitoring or arterial wave form analysis.

结局指标

主要结局

change in stroke volume measured before and after fluid administration in response to beat-to-beat atrial pacing.

时间窗: On day 1

The main study parameter is the change in stroke volume measured before and after fluid administration in response to beat-to-beat atrial pacing. Stroke volume will be assessed using VTI of the LVOT via transthoracic echocardiography. This change will be compared between fluid responders (defined as a ≥10% increase in stroke volume following fluid administration) and non-responders to assess the predictive accuracy of the pacing protocol.

次要结局

  • Arterial wave form analysis (via intra-arterial blood pressure monitoring) to compare the ability of wave form analysis to detect stroke volume changes.(On day 1)
  • Complementation of the clinical findings with computer simulations (CircAdapt) in a comparable virtual cohort of patients(On day 1)

研究者

申办方类型
Other
责任方
Sponsor

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