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Effects of Fluid Balance Control in Critically Ill Patients (POINCARE)

2020年9月21日 更新者:Central Hospital, Nancy, France

Effects of Fluid Balance Control in Critically Ill Patients: A Multicenter Randomized Study

Most ICU patients develop a positive fluid balance, mainly during the two first weeks of their stay. The causes are multifactorial: a reduced urine output subsequent to shock state, positive pressure mechanical ventilation, acute renal failure, post-operative period of major surgical procedures, and simultaneous fluid loading to maintain volemia and acceptable arterial pressure. Additionally, the efficacy of fluid loading is frequently suboptimal, in relation to severe hypoalbuminemia and inflammatory capillary leakage. This results usually in a cumulated positive fluid balance of more than 10 litres at the end of the first week of stay. A high number of studies have showed that such a positive fluid balance was an independent factor of worse prognosis in selected populations of ICU patients: acute renal failure, acute respiratory distress syndrome (ARDS), sepsis, post-operative of high risk surgery. However, little is known about the putative causal role of positive fluid balance by itself on outcome. However, in two randomized controlled studies in patients with ARDS, a strategy of fluid balance control has been demonstrated to reduce time under mechanical ventilation and ICU length of stay with no noticeable adverse effects. Although avoiding fluid overload is now recommended in ARDS management, there is no evidence that this approach would be beneficial in a more general population of ICU patients (i.e. with sepsis, acute renal failure, mechanical ventilation). In addition, fluid restriction -mainly if applied early could be deleterious in reducing both tissue oxygen delivery and perfusion pressure. There is a place for a prospective study comparing a "conventional" attitude based on liberal fluid management throughout the ICU stay with a restrictive approach aiming at controlling fluid balance, at least as soon as the patient circulatory status is stabilized. The latter approach would use a simple algorithm using fluid restriction and diuretics based on daily weighing, a common procedure in the ICU, probably more reliable than cumulative measurement of fluid movements in patients whose limits have been underlined.

研究概览

研究类型

介入性

注册 (实际的)

1411

阶段

  • 不适用

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

      • Belfort、法国、90000
        • Hôpital Nord Franche-Comté
      • Dijon、法国、21000
        • Centre Hospitalier Universitaire
      • Lyon、法国、69000
        • Centre Hospitalier Universitaire
      • Metz、法国、57000
        • Centre Hospitalier Régional
      • Nancy、法国、54000
        • Centre Hospitalier Régional et Universitaire
      • Paris、法国、75000
        • Groupe Hospitalier Saint Joseph
      • Poissy、法国、78303
        • Centre Hospitalier Intercommunal
      • Strasbourg、法国、67000
        • Centre Hospitalier Régional et Universitaire
      • Strasbourg、法国、67000
        • CentreHospitalier Régional et universitaire
      • Thionville、法国、57000
        • Centre Hospitalier Régional
      • Verdun、法国、55100
        • Centre Hospitalier

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 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients under mechanical ventilation, admitted for > 48h and <72h and no discharge planned for the next 24h

Exclusion Criteria:

  • Age < 18 years
  • Failure to weigh the patient
  • Multiple trauma
  • Transfer from another ICU with a previous stay > 24h
  • High probability of withdrawing treatment for ethical purposes within 7 days
  • Pregnancy
  • Patient refusal

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

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Control
Usual care provided according to the ward policy. Patients have to be weighed at least on admission (day 0), day 7 and day 14.
实验性的:Strategy
Patients have to be weighed every day. Use of an algorithm based on weight changes from day 2 to day 14 in order to reduce weight gain (fluid overload) using diuretics, fluid restriction,albumin, and ultrafiltration (the latter when ongoing renal replacement)
Used to reduce fluid overload as evidenced by weight gain
其他名称:
  • 速尿
  • 氢氯噻嗪
  • 布美他尼
Used to reduce fluid overload in addition with diuretics in hypoalbuminemic patients
Used to reduce fluid overload
Used to reduce fluid overload in patients with renal replacement
其他名称:
  • 超滤

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
All-cause mortality at 60 days after inclusion
大体时间:60 days
Vital status collected 60 days after admission; if the patient was dead at the time of assessment, date of death was collected
60 days

次要结果测量

结果测量
措施说明
大体时间
Fluid balance control at day 7
大体时间:7 days
Mean differences of patient body weight between Day 7 and admission (Day 0)
7 days
Fluid balance control at day 14
大体时间:14 days
Mean differences of patient body weight between Day 14 and admission (Day 0)
14 days
All-cause mortality at 28-day after inclusion
大体时间:28 days
Vital status collected 28 days after admission
28 days
All-cause in-hospital mortality
大体时间:Up to 24 weeks
Death during the hospital stay where the patient was included in the study
Up to 24 weeks
All-cause mortality at 365 days after inclusion
大体时间:365 days
Vital status collected one year after admission
365 days
Survival time period at Day 60
大体时间:60 days
Time-related mortality, calculated from admission to the date of death
60 days
Survival time period at Day 365
大体时间:365 days
Time-related mortality, calculated from admission to the date of death
365 days
Global end-organ damage assessment
大体时间:28 days
Time-related changes of Sequential Organ Failure Assessment (SOFA score): SOFA is a score of organ failure with 6 subscales on organ dysfunction: respiratory, neurological, cardiovascular,hepatic,renal and coagulation. Each ranges from 0 to 4 and the total SOFA score is the sum of each subscale ; increasing severity from 0 (normal) to 24(moribund). Values of SOFA score are tightly correlated with mortality.
28 days
Dependence on vasopressor drugs
大体时间:28 days
Cumulated number of vasopressor-free days alive from day 0 to day 28
28 days
Dependence on mechanical ventilation
大体时间:28 days
Cumulated number of ventilator-free days alive from day 0 to day 28
28 days
Dependence on renal replacement therapy
大体时间:60 days
Cumulated number of renal replacement-free days alive from day 0 to day 60
60 days
Cumulated number of pre-defined adverse events
大体时间:14 days
Pre-defined adverse events include Systolic arterial pressure< 90 mm Hg, kalemia < 2,8 ,mmol/L, natremia >155 mmol/L, "injury" level of renal dysfunction (RIFLE scale), acute ischemic events (myocardial infarction, mesenteric ischemia)
14 days

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:El Mehdi SIAGHY、Central Hospital, Nancy, France

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6月1日

初级完成 (实际的)

2019年7月31日

研究完成 (实际的)

2020年5月25日

研究注册日期

首次提交

2016年4月29日

首先提交符合 QC 标准的

2016年5月5日

首次发布 (估计)

2016年5月6日

研究记录更新

最后更新发布 (实际的)

2020年9月22日

上次提交的符合 QC 标准的更新

2020年9月21日

最后验证

2020年9月1日

更多信息

与本研究相关的术语

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

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