Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)– an international multicenter observational cohort study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,500
- 试验地点
- 5
- 主要终点
- The primary outcome is a composite of various aspects of fluid therapy, including total
研究概览
简要总结
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
There is substantial worldwide variation in practice of fluid and vasopressor therapy in critically ill invasively ventilated patients
Study design
International, multicenter, observational study in critically ill invasively ventilated patients; data are captured during a predefined period per geographic region or country.
Study population
Critically ill invasively ventilated patients.
Main study parameter/endpoint
The primary outcome is a composite of various aspects of fluid therapy, including total volumes of types of fluids administered in the first three days after start of invasive ventilation and total volume of fluids infused in the first seven days after start of invasive ventilation. Secondary outcomes include timing of start, type, and duration of continuous administration of vasopressors; timing of start, infusion time and types of administered diuretics; daily urine output and cumulative fluid balances; and typical ICU outcomes, like duration of ventilation, lengths of stay in ICU and hospital, and mortality in the ICU and hospital, and at day–28, –60 and –90.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness
Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts or electronic medical records systems is of no risk to the patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •admitted to a participating ICU
- •receiving invasive ventilation within 3 days of ICU admission and
- •duration of ventilation more than 24 hours.
排除标准
- •Age less than 18 years
- •patients transferred under invasive ventilation from another ICU.
结局指标
主要结局
The primary outcome is a composite of various aspects of fluid therapy, including total
时间窗: At day 3 and day 7 of start of invasive ventilation in ICU
volumes of types of fluids administered in the first three days after start of invasive
时间窗: At day 3 and day 7 of start of invasive ventilation in ICU
ventilation and total volume of fluids infused in the first seven days after start of invasive ventilation.
时间窗: At day 3 and day 7 of start of invasive ventilation in ICU
次要结局
- Secondary outcomes include timing of start, type, and duration of continuous administration of vasopressors; timing of start, infusion time and types of administered diuretics; daily urine output and cumulative fluid balances; and typical ICU outcomes, like duration of ventilation, lengths of stay in ICU and hospital, and mortality in the ICU and hospital.(At day 28, 60 and 90)
研究者
Dr Sheila Nainan Myatra
Tata Memorial Hospital