Fluid Administration and Fluid Accumulation in the Intensive Care Unit (FLUID-ICU) - an International Inception Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,755
- 试验地点
- 21
- 主要终点
- The number of patients with fluid accumulation.
研究概览
简要总结
The goal of this international inception cohort study is to describe fluid administration during admittance to the intensive care unit (ICU), and provide contemporary epidemiological data on fluid accumulation, risk factors, management and outcome in critically ill adult patients.
详细描述
Background: Fluid accumulation is associated with adverse outcome in ICU patients, however, assessment of fluid status is often difficult and no established definition and consistent detection method exists. Former research has primarily focused on the use of resuscitation fluid, but a substantial amount of fluid is administered throughout the entire ICU stay and this fluid may be a clinically relevant source of fluid accumulation.
Objectives: To describe fluid administration practices during the entire ICU stay, and provide contemporary epidemiological data on fluid accumulation, fluid removal, risk factors and association with patient outcomes from a worldwide perspective.
Study design: International inception cohort study. Patients will be included during a 14-day inception period to be chosen by each participating site.
Population: Critically ill adult patients (≥ 18 years) with acute admission to the ICU.
Intervention: None. Only routinely available data will be collected.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute admission to the ICU during the 14-day inception period.
- •Adults (≥ 18 years).
排除标准
- •Patients previously included in the FLUID-ICU study.
- •Patients with major burns (≥ 10% of body surface)
结局指标
主要结局
The number of patients with fluid accumulation.
时间窗: From ICU admission to discharge (with a maximum of 28 days).
The presence of fluid accumulation is defined as the best clinical estimate made by the study investigators, using medical records and the treating team's clinical assessment, and one or more of the following parameters: Cumulative fluid balance, daily fluid balance, changes in body weight, and/or clinical signs of fluid accumulation (e.g. peripheral oedema, pulmonary oedema, congestion on chest X-ray or lung ultrasound).
次要结局
- Number of patients developing fluid accumulation during the ICU stay.(28 days)
- Number of days with fluid accumulation during the ICU stay.(28 days)
- Days alive and out of hospital within 90 days from ICU admission.(90 days)
- Mortality within 90 days from ICU admission.(90 days)
- Number of patients with fluid accumulation upon ICU admission (baseline).(On the first day of ICU admission (Day 1).)
- Number of patients being treated with 'active fluid removal' (use of diuretics, or renal replacement therapy).(28 days)
- Days alive without use of life-support within 28 days from ICU admission.(28 days)