Fluid Responsiveness Evaluation by a Non-invasive Method in CHildren - The FRENCH Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness
研究概览
简要总结
In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in children with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion).
详细描述
Fluid expansion is the cornerstone of acute circulatory failure treatment in children Although this therapy drastically reduced mortality, several studies in recent years have highlighted the adverse effects of excessive fluid expansion (leading to fluid overload). Currently, the search for indicators to predict fluid responsiveness is a major issue in intensive care. These indicators are based on Franck-Starling's law: if small changes in preload lead to an increase in cardiac output, then fluid responsiveness can be expected. However, in children, the only validated indicator (respiratory variability of peak aortic velocity) can only be used in the absence of any spontaneous respiratory movement, a rare situation in practice. Recently, two pediatric studies investigated a simple clinical test: hepatic or abdominal compression. This clinical maneuver, by increasing venous return via mobilization of the hepato-splanchnic reserve, induces a transient and reversible preload increase. The evaluation of the hemodynamic effects of this "endogenous fluid expansion" allowed, according to the authors, to accurately predict fluid responsiveness. However, several factors reduce the applicability of these results: the small number of studies on this subject, the smaller volume of fluid used than in clinical practice, and the population studied, composed almost exclusively of children in postoperative of cardiac surgery.
In this study, the investigators will evaluate the diagnostic accuracy of abdominal compression for the diagnosis of fluid responsiveness in children with acute circulatory failure, hospitalized in pediatric intensive care unit (PICU) for a medical or a non-cardiac surgical condition, for whom a fluid expansion was prescribed by the physician in charge. The index test will be the stroke volume variation following a standardized abdominal compression (before fluid expansion). The gold standard test will be the variation of cardiac output between baseline and after fluid expansion, a variation > 15% defining fluid responsiveness.
In this non interventional study of diagnostic accuracy, patients will undergo an extra echocardiographic assessment, but no supplemental blood test or invasive parameters will be collected. Simple clinical parameters will be collected within 4 hours after the fluid expansion. Patients will be follow-up until PICU discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age lower than 15 years old
- •Prescription of a 10 to 20ml/kg crystalloid fluid expansion by the physician in charge
- •Acute circulatory failure defined by the association of an A criteria (increase of heart rate more than two standard deviation for the age, decrease of systolic or mean blood pressure more than two standard deviation for ) and a B criteria (lactate more than 2 mmol/L, oliguria less than 1mL/kg/h, a capillary filling time more than 3 seconds, mottling)
- •Patient hospitalized in PICU
排除标准
- •Prematurity (term below 37 gestational week).
- •Acute cardiogenic pulmonary edema
- •Hemodynamic instability making the delay necessary for abdominal compression and ultrasonography dangerous for the patient
- •Non corrected congenital cardiopathy, or inferior to 15 days postoperative.
- •Intra-abdominal hypertension or painful abdominal palpation
- •Abdominal surgery in the last 15 days
- •Supine position contraindicated or deleterious
- •No investigator available to assess ultrasonographic measures
- •Impairment of echocardiographic acoustic window or restless patient making ultrasonography impossible
结局指标
主要结局
Diagnostic accuracy of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness
时间窗: after abdominal compression, 30 minutes to 4 hours after baseline
Diagnostic accuracy of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, defined by an increase of cardiac output \> 15% after fluid expansion (ΔCO-FE \> 15%, gold-standard test) Index test (ΔSVi-AC) will be calculated as the difference between Stroke Volume (SV) after abdominal compression and SV at baseline, divided by SV at baseline (%). SV will be measured by echocardiographic assessment. Gold-standard test (ΔCO-FE) will be calculated as the difference between CO after fluid expansion and CO at baseline, divided by CO at baseline (%). CO will be measured by echocardiographic assessment.
次要结局
- Association between elevated ΔSVi-AC and Heart rate (bpm). -after abdominal compression(after abdominal compression, 30 minutes to 4 hours after baseline)
- Association between elevated ΔSVi-AC and capillary filling time (sec) -after abdominal compression(after abdominal compression, 30 minutes to 4 hours after baseline)
- Association between elevated ΔSVi-AC and Heart rate (bpm). -Baseline(at baseline (before fluid expansion))
- Association between elevated ΔSVi-AC and urine output (ml/kg/h). -Baseline(at baseline (before fluid expansion))
- Association between elevated ΔSVi-AC and urine output (ml/kg/h). -after abdominal compression(after abdominal compression, 30 minutes to 4 hours after baseline)
- Association between elevated ΔSVi-AC and capillary filling time (sec) -Baseline(at baseline (before fluid expansion))
- Association between elevated ΔSVi-AC and Blood lactate (mmol/L). -Baseline(at baseline (before fluid expansion))
- Association between elevated ΔSVi-AC and Central venous oxygen saturation (%). -Baseline(at baseline (before fluid expansion))
- Association between elevated ΔSVi-AC and Mean blood pressure (mmHg). -Baseline(at baseline (before fluid expansion))
- Association between elevated ΔSVi-AC and Mean blood pressure (mmHg). -after abdominal compression(after abdominal compression, 30 minutes to 4 hours after baseline)
- Association between elevated ΔSVi-AC and Central venous oxygen saturation (%). -after abdominal compression(after abdominal compression, 30 minutes to 4 hours after baseline)
- Association between elevated ΔSVi-AC and Blood lactate (mmol/L). -after abdominal compression(after abdominal compression, 30 minutes to 4 hours after baseline)