Fluid Challenge in Intensive Care: a Worldwide Global Inception Cohort Study: The FENICE II Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 4,734
- Locations
- 2
- Primary Endpoint
- Composite of various aspects of fluid therapy
Study Overview
Brief Summary
Fluids are considered the primary treatment for critically ill patients admitted to the intensive care unit (ICU), aiming to replace losses and or to enhance venous return, stroke volume, and consequently, cardiac output and tissue oxygen delivery. The modalities, volumes, and targets employed to titrate fluid therapy vary significantly in current clinical practice, as shown by the original FENICE study 10 years ago. FENICE studied how fluid challenges are given at the bedside. Very little is known about how this practice has changed since, how fluid administration (maintenance) is performed in general, and how the modality may impact outcomes. FENICE II is designed to explore these issues.
Objectives:
To provide a comprehensive global description of fluid administration modalities during the initial days of ICU admission and to explore any association between fluid administration characteristics and clinical outcomes.
To describe the fluid challenge administration modality and appraise the use of variables and functional hemodynamic tests to guide bolus infusion.
Detailed Description
Primary aim: The primary aim is to describe the modality of fluid administration during the first 5 days of ICU stay considering 1) the overall fluid balance; 2) the characteristics of the fluids given; 3) the modality of fluid administration.
Secondary aims:
- To explore any association between fluid administration characteristics and clinical outcomes (see further)
- To evaluate factors potentially associated with the respective proportion of the different modalities of fluid administration
- To characterize FC administration modality in a large cohort of ICU patients.
Statistical Analysis:
Data will be described as median and interquartile range (IQR) or number and percentage. Categorical variables were compared using Fisher's exact test and continuous variables using the nonparametric Wilcoxon test, Mann-Whitney test, or Kruskal-Wallis test.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All consecutive adult (≥18 years old) patients admitted to ICU and expected to stay at least 48h.
Exclusion Criteria
- •Planned admission after surgery for overnight ICU stay.
- •Refusal of consent
- •Moribund patients (i.e. expected survival < 24h)
Outcomes
Primary Outcomes
Composite of various aspects of fluid therapy
Time Frame: FIve days from ICU admission
Modality of fluid administration during ICU stay considering 1) the overall fluid balance; 2) the characteristics of the fluids given; 3) the modality of fluid administration
Secondary Outcomes
- ICU mortality(Up to 30 days from ICU admission)
- In-hospital Mortality(Up to 30 days from ICU admission)
- Alive without any organ support(between inclusion and 30 days later)
- Organ Dysfunction - Lung(between inclusion and 30 days later)
- Organ Dysfunction - Heart(between inclusion and 30 days later)
- Organ Dysfunction - Renal(between inclusion and 30 days later)
- Organ Dysfunction(between inclusion and 5 days later)
- Organ Dysfunction - Renal(between inclusion and 5 days later)