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临床试验/NCT07131228
NCT07131228尚未招募不适用

Changes in Portal Vein Pulsatility Variability During a Tidal Volume Challenge Can Predict Fluid Tolerance

Dr. Negrin University Hospital0 个研究点目标入组 60 人开始时间: 2026年11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
发起方
入组人数
60
主要终点
The absolute change in the portal pulsatility index measured in critically ill patients immediately before and after an incraese of voclumen tidal (6 to 8 ml/kg) . Measurements will be obtained using Doppler ultrasonography in vena porta.

研究概览

简要总结

In critically ill patients, appropriate fluid administration is one of the cornerstones of hemodynamic management, as both hypovolemia and fluid overload can negatively impact clinical outcomes.

For years, fluid responsiveness-defined as an increase in cardiac output following volume administration-has guided decision-making in the postoperative ICU. However, fluid responsiveness alone does not guarantee fluid tolerance, which refers to the venous system's ability to accommodate volume without developing venous congestion or adverse effects such as pulmonary edema, renal or hepatic dysfunction.

The tidal volume challenge (TVC)-which consists of a transient increase in tidal volume from 6 to 8 mL/kg-has been shown to predict fluid responsiveness by enhancing the hemodynamic interaction between the heart and lungs during the cardiac cycle, as measured through dynamic arterial indices such as pulse pressure variation (PPV) or stroke volume variation (SVV). However, these indices do not provide information about fluid tolerance or the state of venous congestion.

Doppler ultrasound of the portal vein, specifically the portal pulsatility index (which under normal conditions presents as a continuous waveform due to the damping effects of the hepatic parenchyma and venous compliance), has been proposed as a non-invasive marker of systemic venous congestion. Studies have shown that an increase in the portal pulsatility index following volume loading may indicate the development of venous congestion and, therefore, poor fluid tolerance.

Since the tidal volume challenge transiently increases intrathoracic pressure and allows dynamic evaluation of cardiovascular responses, we propose that this interaction be assessed not only through arterial dynamic indices (which assess responsiveness) but also through changes in venous flow patterns-specifically, variations in portal pulsatility-so that both fluid responsiveness and tolerance can be predicted with the same test.

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

  • •Participants must meet all of the following:
  • •Age ≥ 18 years at the time of enrollment.
  • •Receiving controlled mechanical ventilation with a baseline tidal volume of 6 mL/kg of predicted body weight.
  • •Clinical indication for assessment of fluid responsiveness.
  • •Adequate acoustic window for ultrasound visualization of the portal vein.

排除标准

  • •Participants will be excluded if they have any of the following:
  • •Liver cirrhosis.
  • •Right heart failure, defined as any of the following on prior echocardiography:
  • •Tricuspid annular plane systolic excursion (TAPSE) < 16 mm
  • •S' wave < 10 cm/s
  • •Right ventricular fractional area change < 35%
  • •Left heart failure (left ventricular ejection fraction < 50%).
  • •Intra-abdominal hypertension.
  • •Atrial fibrillation or other significant cardiac arrhythmias.
  • •Tricuspid regurgitation.
  • •Poor echogenic window preventing adequate ultrasound assessment.
  • •Presence of spontaneous breathing activity.

结局指标

主要结局

The absolute change in the portal pulsatility index measured in critically ill patients immediately before and after an incraese of voclumen tidal (6 to 8 ml/kg) . Measurements will be obtained using Doppler ultrasonography in vena porta.

时间窗: Measured immediately before and after the tidal volume challenge (1 minute).

次要结局

  • To correlate changes in portal pulsatility during the test with clinical signs of fluid intolerance (e.g., acute kidney injury, pulmonary congestion).(Assessed during the first 48 hours post-challenge.)

研究者

发起方
Dr. Negrin University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucia Valencia

Intensive Care Unit Attending Physician

Dr. Negrin University Hospital

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