Timing and Dose of Fluid Deresuscitation in Critically Ill Patients: a Prospective Observational Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Successful deresuscitation without hemodynamic consequences
研究概览
简要总结
Fluid deresuscitation is an important intervention in the Intensive Care Unit (ICU). This study aims to find (1) determinants of successful deresuscitation, (2) the optimal rate (dose) of deresuscitation based on these determinants, and (3) differences in metabolic profiles for a more personalized approach of deresuscitation.
This study is a multicenter, prospective, observational cohort study in critically ill patients. This study will include ICU patients who have a clinical indication for deresuscitation as set by the treating physician. Clinical, ultrasound and laboratory values will be collected and used for analysis.
详细描述
Primary objective:
The aim of this study is to identify determinants of successful deresuscitation in ICU patients, defined as achieving a negative fluid balance within 24 hours without hemodynamic consequences.
Secondary objectives:
-
Timing of deresuscitation:
-
Identify determinants of successful deresuscitation in ICU patients, defined as achieving a negative fluid balance within 24 hours;
-
Compare these determinants with determinants for the clinical decision of deresuscitation by the treating physician;
-
Identify differences in these determinants within subgroups of sepsis, ARDS and cardiac patients, provided the numbers are sufficient;
-
Rate (dose) of deresuscitation:
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
- •Admission to one of the participating ICUs;
- •Clinical indication for deresuscitation using diuretics or ultrafiltration as set by the treating physician; first attempt during the ICU stay.
排除标准
- •Age below 18 years old;
- •Major cardiac shunts;
- •Moderate to severe aortic regurgitation;
- •Morbid Obesisty (BMI >40);
- •POCUS impossible or unreliable (i.e. pre-existing interstitial lung disease);
- •PLR or modified form of PLR impossible (i.e. ECMO);
- •Transfer from another ICU;
- •Previous inclusion in this study;
- •Patients who are moribund or facing the end of life;
结局指标
主要结局
Successful deresuscitation without hemodynamic consequences
时间窗: 24 hours
Reach negative fluid balance in first 24 hours without hemodynamic consequences (yes/no), defined as either hypotension or hypoperfusion: 1. Hypotension * Interventions required to maintain blood pressure MAP \> 65mmHg * Deresuscitation is stopped * Fluid bolus needs to be given * Noradrenaline (or other vasopressor) needs to be initiated, increased to \> 0.2 microg/kg/min, or increased by 50% * Dose reduction or interruption of RRT 2. Hypoperfusion (one of the following): * Arterial lactate level \>3 and/or increased 25% or more * New development of mottled skin * Capillary refill time \> 3 seconds * New oliguria (urine output \< 0.3-0.5ml/kg/hour for the previous 6 hours)
次要结局
- 28-day mortality(28 days)
- Successful deresuscitation(24 hours)
- Rate of deresuscitation(24 hours)
- Dose of deresuscitation(24 hours)
- Natriuresis(24 hours)
- Delta Strong Ion Difference(24 hours)
- Delta serum sodium(24 hours)
- Delta serum chloride(24 hours)
- Atrial fibrillation(24 hours)
- Acute Kidney Injury (AKI)(7 days)
- Persistent AKI(7 days)
- Renal Replacement Therapy (RRT)(7 days)
- Delirium(7 days)
- ICU-mortality(28 days)
- Ventilator free days (VFD)(28 days)
- ICU length of stay (LOS)(28 days)
研究者
P.R. Tuinman
Prof. Dr. P.R. Tuinman
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)