NCT01590511已完成不适用
Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2013年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2)
研究概览
简要总结
The main objective of this study is to show that the variation of the subaortic velocity time integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100) is predictive of response to filling (defined as an increase in aortic velocity time integral measured by transthoracic ultrasound over 15% after administration of 500 cc of normal saline over 15 minutes) in non-ventilated shock patients.
详细描述
The secondary objectives of this study include:
- To determine the sensitivity and specificity of the variation of the velocity time integral after administration of 100 cc of normal saline over 1 minute (ΔITV100) to predict the response to the filling.
- To study the inter-observer variation of ΔITV100 measurement.
- To compare ΔITV100 to other clinical and radiological parameters for predicting response to filling (initial value of the subaortic velocity time integral, variation in mitral E wave, E / A, respiratory variation of the diameter of the inferior vena cava, marbling clinical evolution score.
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
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •Systolic blood pressure (SBP) < 90 mmHg
- •Signs of inadequate cardiac output: urine output <0.5 ml / kg / h for more than two hours, hyperlactataemia
- •Requires amines to maintain an SBP ≥ 90 mmHg or inability to lower amines or requires an increase in amines
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient (or his/her person-of-trust) refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patients has a contraindication for a treatment necessary for this study
- •Cardiogenic shock
- •Acute pulmonary edema
- •Moribund patient
- •Non echogenic patient
- •Patient with cardiac arrhythmia
- •Patients for whom the passive leg raising test is contraindicated (hyper intra-abdominal pressure, pelvic or lower limb trauma)
结局指标
主要结局
Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2)
时间窗: baseline; 26 minutes
次要结局
- Change if the subaortic velocity time integral after a passive leg raising trial (cm^2)(baseline; 15 minutes)
- Change in mean arterial pressure after the "mini-fluid challenge" (mmHg)(baseline; 26 minutes)
- Change in the E/A ratio after the "mini-fluid challenge"(baseline; 26 minutes)
- Change in the Marbrure clinical score after the "mini-fluid challenge"(baseline; 26 minutes)
- Change in lower vena cava diameter(baseline; 8 minutes)
- Change in heart rate after the "mini-fluid challenge"(baseline; 26 minutes)
- Change in mitral E wave (cm / s) after the "mini-fluid challenge"(baseline; 26 minutes)
研究者
研究点 (1)
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