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临床试验/NCT05968066
NCT05968066已完成不适用

Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)--an International Multicenter Observational Cohort Study

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 2,508 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,508
试验地点
1
主要终点
Composite of various aspects of fluid therapy

研究概览

简要总结

The goal of this woldwide observational study is to investigate various aspects of fluid and vasopressor therapy in critically ill invasively ventilated patients. The main questions it aims to answer are:

  • What is the global current practice of fluid and vasopressor therapy?
  • What are associations between this practice and clinical outcomes?

Participating intensive care units will gather detailed information about fluid and vasopressor therapy prescribed to participants. Participating intensive care units will also gather information about participant outcomes such as duration of invasive ventilation, length of stay and mortality

详细描述

Rationale:

The worldwide practice of fluid and vasopressor therapy in critically ill invasively ventilated patients is uncertain. Indeed, it is unclear whether there is a difference in fluid and vasopressor therapy in these patients between Low- and Middle-income Countries (LMICs) and High-income Countries (HICs).

Objective:

To determine various aspects of fluid and vasopressor therapy in critically ill invasively ventilated patients in LMICs and HICs.

Hypothesis:

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to a participating intensive care unit;
  • Receiving invasive ventilation; and
  • Duration of ventilation > 24 hours.

排除标准

  • Age < 16 years;
  • Patients transferred under invasive ventilation from another intensive care unit.

结局指标

主要结局

Composite of various aspects of fluid therapy

时间窗: seven days

Including total volumes of types of fluids administered in the first three days after ICU admission and total volume of fluids infused in the first seven days of ICU admission

次要结局

  • Types of vasopressors(seven days)
  • Timing of start of administered diuretics.(seven days)
  • Duration of diuretic therapy(seven days)
  • Incidence of atrial arrythmias(7 days)
  • Duration of vasopressor therapy(seven days)
  • Concentration of types of vasopressors(seven days)
  • Daily urine output(seven days)
  • Incidence of need for renal replacement therapy at ICU discharge.(90 days)
  • Bolus or continous infusion of diuretics(seven days)
  • Incidence of acute respiratory distress syndrome(7 days)
  • Types of diuretics(seven days)
  • Incidence of renal replacement therapy(7 days)
  • Typical ICU outcomes; e.g. duration of ventilation, lengths of stay in ICU and hospital and, mortality in the ICU and hospital(90 days)
  • Timing of start of continuous administration of vasopressors.(seven days)
  • Cumulative fluid balances(seven days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Marcus J. Schultz

Prof. Dr.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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