Fluid Challenge in Intensive Care: a worldwide global inception cohort study.  The Fenice II study.

 

Research question?

What is the modality of fluid administration in ICU patients worldwide and what is the impact of fluid administration on clinical outcomes?

Background

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 haemodynamic tests to guide bolus infusion.

Study design

Prospective multicentre worldwide study.

Population

Inclusion criteria:

• All consecutive adult patients (≥ 18 years) admitted to ICU and expected to stay at least 48h.

Exclusion criteria:

• Refusal of consent.
• Planned admission after surgery for overnight ICU stay.
• Moribund patients (i.e. expected survival < 24h).

Enrollment and study periods: We have two data collection periods to choose from:

The phase of centers enrolment will be conducted over a time window of 12 months starting from 1st January 2024.

The phase of patients’ enrolment will be conducted over a two-weeks period (14 days), chosen within a time window of 6 months starting from 1st January 2025.

The study period for data collection regarding the modality of fluid administration will consider the first 5 days from ICU admission (ICU days 1-5).

Aims

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.

 Clinical outcomes:

• In-hospital, intensive care unit, and 30-day mortality.
• Major organ dysfunction: lungs, heart and circulatory system, kidneys.
• Variation in SOFA score within 7 days from admission.

Functional outcomes:

• Volume of resuscitation fluids within 5 days from admission, type of fluid, and modality of administration.

Net daily fluid balance within 5 days.

Data Collection

Data All data generated in participating centres will be systematically recorded using the study management software RedCap (Research Electronic Data Capture) and uploaded through a secure connection to an encrypted database in Humanitas Research Hospital (Milan, Italy) servers.

Study Duration

The enrollment phase of the study will span a two-week period during the 2024. This time frame follows a preliminary period dedicated to trial dissemination and the recruitment of participating centers. Data collection regarding the modality of fluid administration will be focused on the first 5 days of ICU admission.

Safety

The study will be based on descriptive variables from routine available data and will not affect treatment or handling of the patients included (observational study).

Authorship

Centres’ coordinators and site investigators will be acknowledged either on the front page or under the group authorship (“FENICE II Study Group”) with the specific order determined by factors such as the number of included patients per study site, overall commitments, and centres’ recruitment. For multiple coordinators and/or investigators, authorship criteria will be evaluated at the end of the by the Steering Committee.