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Fluid Responsiveness Evaluation by AbdomiNal Compression in Kids Based on the STARLING Concept (FRANCK)

2016年12月25日 更新者:Matthias Jacquet-Lagrèze、Hopital Louis Pradel

Purpose:

Fluid responsiveness in a context of circulatory failure can be predicted by different way. Dynamic criteria such as pulse pressure variation, stroke volume variation during an end-expiratory occlusion maneuver or a passive leg raising have been reported to predict fluid responsiveness. Only aortic velocity peak variation measured with transthoracic echocardiography during mechanical ventilation has been reported to predict fluid responsiveness in children. Besides some physician use a maneuver of abdominal compression to predict fluid responsiveness in children with circulatory failure. This strategy has never been formally evaluated.

The investigators will study the diagnosis accuracy of the stroke volume variation induced by an abdominal compression to predict stroke volume variation after 10 ml/kg fluid load in children with circulatory failure.

Thirty-eight pediatric patients under eight years old in circulatory failure, for whom the attending physician has decided a fluid load will be included. Hemodynamic parameters: arterial pressure, heart rate, stroke volume measured with echocardiography; will be recorded. This data collection will be performed before, after abdominal compression and after a fluid load of 10 ml/kg.

Patients will be aposteriori sorted in two groups: Fluid responders and Fluid non-responders. Fluid responders are defined as patients that show an increase greater than 15 % in stroke volume. The diagnosis ability of the Stroke volume variation after an abdominal compression to predict fluid responsiveness will be investigate and receiving operative characteristic (ROC) curve will be built. The correlation between the variation of stroke volume during abdominal compression and during the fluid load will be studied. Other parameters such as arterial pressure and heart rate will also be investigated.

研究概览

研究类型

观察性的

注册 (实际的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lyon、法国
        • Intensive care and anesthesiology department, Hôpital Louis Pradel.
      • Lyon、法国
        • Pediatric Intensive care, Hôpital Femme Mère Enfant

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 8年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patient hospitalized in the intensive care unit of the hospital " feme mère enfant " or the cardiologic hospital of BRON who suffer from circulatory failure and for whom the attending physiscian has decided to administer a 10 ml/kg cristalloïd infusion.

描述

Inclusion Criteria:

  • Age < 8 years old
  • Patient with a circulatory failure defined as follow :

Treatment including vasopressor or inotrope

OR macrocirculatory failure

  • Heart rate > 2 Standard Deviation (SD)
  • Systolic arterial pressure < 2 SD
  • Mean arterial pressure < 2 SD
  • Diastolic arterial pressure < 2 SD

WITH signs of microcirculatory failure

  • Capillary refill time > 2 secondes
  • Blotch
  • Organ dysfunction due to the circulatory failure (Oliguria < 0,5 ml/kg/h, acute lung injury, encephalopathy)

Exclusion Criteria:

  • Opposition from the parents or the one who holds the parental authority
  • Cardiogenic acute pulmonary edema,
  • Extreme hemodynamic instability,
  • Intra-abdominal hypertension,
  • Recent abdominal surgery that does not permit an abdominal compression without causing pain.
  • Patient with mechanical circulatory support, such as Extra Corporal Life Support or Berlin-Heart
  • Patient with congenital cardiopathy with a palliative correction or an incomplete correction
  • Open thorax
  • Prone position
  • Investigators not available
  • No security number registration.
  • Moribund patient

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Ability of the stroke volume variation after abdominal compression to predict fluid responsiveness
大体时间:30 minutes
Stroke volume will be measured before and after a calibrated abdominal compression and after a fluid load. Patient will then be sorted in two groups. Responders defined as patient that show an increase in stroke volume after a 10ml/kg fluid load and Fluid non responders, defined as patient that show an increase of less than 15 % in stroke volume. The ROC curve will investigate the ability of stroke volume variation after abdominal compression to predict fluid responsiveness.
30 minutes

次要结果测量

结果测量
大体时间
Ability of the pulse pressure variation after abdominal compression to predict fluid responsiveness
大体时间:30 minutes
30 minutes
Ability of the heart rate variation after abdominal compression to predict fluid responsiveness
大体时间:30 minutes
30 minutes
Correlation between stroke volume variation, heart rate variation, pulse pressure variation between the abdominal compression and the fluid load
大体时间:30 minutes
30 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Jean-Luc Fellahi, MD, PhD、Hôpital Louis Pradel, Hospice Civil de Lyon

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年7月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2016年12月1日

研究注册日期

首次提交

2015年7月16日

首先提交符合 QC 标准的

2015年7月21日

首次发布 (估计)

2015年7月22日

研究记录更新

最后更新发布 (估计)

2016年12月28日

上次提交的符合 QC 标准的更新

2016年12月25日

最后验证

2016年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • EudraCT/ANSM 2015-A00388-41

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