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Time Course Evolution of Cardiac Output (TCCO)

Time Course Evolution of Cardiac Output in Critically Ill Patients After a Fluid Expansion

Fluid expansion is the first therapeutic option in patients presenting acute circulatory failure but the duration of its hemodynamic effects (persistency and time of maximal increase in cardiac output) is unknown.

This study is seeking to describe in critically ill patients, the time course evolution of cardiac output over a 2-hours period after a fluid expansion.

The objectives are:

  1. to identify patterns of fluid responsiveness
  2. to determine the time when the maximal increase in cardiac output occurs during and a after fluid expansion
  3. to compare patients' characteristics between patterns

Patients with acute circulatory failure will be recruited as soon as a fluid expansion will be decided by the physician in charge and the effects of fluid expansion on hemodynamic indices (cardiac output, arterial pressure) will be continuously recorded through a transpulmonary thermodilution device over a 2-hours period.

No changes in ventilatory settings nor vasopressors or sedatives will be allowed during the study.

Patients will be categorized into patterns according to the changes in cardiac output after fluid expansion and their characteristics will be compared.

研究概览

地位

完全的

详细说明

The study will be conducted in four medico-surgical ICUs in France between April 2016 and April 2018.

Since fluid challenge and invasive monitoring by thermodilution device is standard of care for septic shock management, the institutional review board waived patient consent. All patients and/or their next of kind will receive written information.

Eligible patients will have to present an acute circulatory failure for whom the physician in charge will decide to start a fluid expansion.

Hemodynamic variables will be obtained through transpulmonary thermodilution and pulse contour analysis (PICCO2 device, Pulsion Germany).

Fluid expansion will consist in the infusion of 500 ml of saline through a central venous catheter in a standardized 10-minutes period. The duration of infusion will be controlled by an airbag pressurized at 300 mmHg.

Fluid responsiveness will be defined by an increase in cardiac output over 15-per-cent from baseline (before fluid expansion).

Study design:

At time of decision to make the fluid expansion, a calibration of the PICCO2 device will be performed and a first set of hemodynamic measurements will be collected (cardiac output, cardiac function index, extravascular lung water, permeability vascular pulmonary index, global end diastolic volume, arterial pressure, heart rate).

Then, fluid expansion will be administrated in less than 10 minutes. From the start of fluid expansion to the end of the two-hours period ot time, pulse contour cardiac output and arterial pressure will be continuously recorded.

During the whole two hours period, no change in vasopressor dosage nor mechanical ventilation settings will be allowed.

In case of hemodynamic instability, defined by a mean arterial pressure under 65mmHg, a new fluid expansion could be realized. In this last case, the protocol will start again from the beginning.

研究类型

观察性的

注册 (实际的)

58

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

18年 至 99年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Critically ill patients admitted in the intensive care unit receiving mechanical ventilation and presenting an acute circulatory failure.

描述

Inclusion Criteria:

  • acute circulatory failure (infusion of norepinephrine)
  • invasive mechanical ventilation through an endotracheal tube
  • decision of fluid expansion

Non inclusion Criteria:

  • extracorporeal membranous oxygenation (ECMO)
  • active bleeding
  • continuous renal replacement therapy with weight loss
  • administration of diuretics within the past six hours
  • decision of therapeutic limitation,
  • age under eighteen years

Exclusion criteria:

  • hemodynamic instability after fluid expansion (mean arterial pressure < 65mmHg)

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

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Patients
The patients will receive a 500 ml fluid expansion over a standardized 10 minutes period
The fluid expansion will consist in a less than 10 min infusion of 500 milliliters of saline through a central venous catheter (jugular). The duration of infusion will be controlled by an airbag pressurized at 300 mmHg.

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
Change in cardiac output during fluid expansion
大体时间:10 minutes
Difference between maximal cardiac output during fluid expansion and baseline
10 minutes

次要结果测量

结果测量
措施说明
大体时间
Change in cardiac output after fluid expansion
大体时间:2 hours
Change in cardiac output after fluid expansion
2 hours

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

  • 首席研究员:Martin Dres, MD, PhD、APHP

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 (实际的)

2016年4月15日

初级完成 (实际的)

2018年5月15日

研究完成 (实际的)

2018年5月31日

研究注册日期

首次提交

2018年10月2日

首先提交符合 QC 标准的

2018年10月2日

首次发布 (实际的)

2018年10月3日

研究记录更新

最后更新发布 (实际的)

2018年10月4日

上次提交的符合 QC 标准的更新

2018年10月3日

最后验证

2018年10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

  • ADOREPS

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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