Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Fluid responsiveness
研究概览
简要总结
Fluid administration is the first-line treatment in hypovolemic states in critically ill patients. Prediction of fluid responsiveness is possible with echocardiography by assessing the variation of the sub-aortic velocity-time integral (AoVTI) during a passive leg raising test (PLR) or Mini-fluid challenge. However, VTI-Ao measurement is not feasible in all patients due to poor echogenicity. Validation of new fluid-responsiveness indices may facilitate the evaluation in this patient population. Among the available indices, variation of the sub-pulmonary VTI is a potential criterion.
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
- •Patient with measurable sub-pulmonary VTI in at least one of the two windows: parasternal short-axis or subcostal.
- •Patient with measurable sub-aortic VTI in apical 4-chamber view before and after PLR maneuver.
- •Patient with suspected hypovolemia or whose hemodynamic status justifies vasopressor infusion.
排除标准
- •Severe left ventricular dysfunction defined by left ventricular ejection fraction (LVEF) < 30%.
- •Severe right ventricular dysfunction defined by TAPSE < 12 mm.
- •Cardiac arrhythmia or atrial fibrillation.
- •Abdominal compartment syndrome.
- •Amputation of one or both lower limbs.
- •Intracranial hypertension.
- •Pregnant women (ruled out by systematic pregnancy test at ICU admission).
研究组 & 干预措施
Patients suspected of hypovolemia
Patients with suspected hypovolemia who need to be evaluated for fluid responsiveness
干预措施: Fluid bolus administration (Drug)
结局指标
主要结局
Fluid responsiveness
时间窗: T0 : baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution
Echocardiographic measurement of subaortic velocity time integral (AoVTI) in apical 5-chambers view is performed before (T0 = Baseline) and within 10 mins (T2) after fluid administration. An increase of 15% or more of AoVTI after fluid administration of 500mL of a crystalloids solution compared to baseline define fluid responsiveness.
Ability of sub-pulmonary VTI variation to predict fluid responsiveness
时间窗: T0 : Baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution
The sub-pulmonary VTI variation (in %) between T0 and T1 is mesured with echocardiography from a transthoracic view (short axis parasternal and sub costal views depending of patient's echogenicity) Sub-pulmonary VTI variation ability to detect fluid responsiveness is assessed by constructing ROC curves to detect the best cut-off.
次要结局
- Sub-pulmonary VTI values description(T0 : baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution)
研究者
Gary DUCLOS
MD, MSc
Aix Marseille Université