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Fluid Challenge in Intensive Care The FENICE II Study

Recruiting
Conditions
Critical Illness
Septic Shock
Registration Number
NCT06394947
Lead Sponsor
Humanitas Clinical and Research Center
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.

Volume of fluid and fluid balance (primary outcome) will be reported as median \[IQR\] from day 1 to day 5. This volume, fluid balance and respective volume of bolus and continuous fluid administration will be reported as distinct alluvial plots reporting median of fluid at day 1 to 5 per quartile along with outcome.

In way to assess relationship between volume of fluid received, characteristics and outcome (secondary outcome), longitudinal cluster modelling will be used to identify clusters of patients with similar patterns of fluid administration profile. Longitudinal k-mean will be used to assess change in fluid received each day from day 1 to day 3. In way to avoid misinterpretation of findings due to time dependent competing events such death or ICU discharge, this analysis will be performed on patients alive and still in the ICU at day 3. A sensitivity analysis will be performed during first 5 days on the subgroup of patients alive and not discharged during first 5 ICU-days.

In way to assess impact of fluid administration modality/strategy on outcome (secondary endpoint), factors associated with in-hospital mortality, including identified cluster of fluid administration, will be assessed using mixed logistic regression where in-hospital mortality will be event of interest. Center effect will be included as a random effect against the intercept.

For secondary outcomes, and in particular for day-30 mortality, number of days alive without vasopressors, mechanical ventilation or renal replacement therapy, will be assessed using survival analysis.

All tests will be two-sided, and P-value less than 0.05 will be considered statistically significant.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
10000
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Composite of various aspects of fluid therapyFIve 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 Outcome Measures
NameTimeMethod
ICU mortalityUp to 30 days from ICU admission

Mortality during ICU stay

In-hospital MortalityUp to 30 days from ICU admission

Mortality during hospital stay after ICU discharge

Alive without any organ supportbetween inclusion and 30 days later

Number of calendar days between inclusion and 28 days that the patient is alive and with no requirement of cardiovascular, respiratory and renal support.

Organ Dysfunction - Lungbetween inclusion and 30 days later

Time to cessation of mechanical ventilation during ICU stay \[The number of calendar days between intubation / start of mechanical ventilation and extubation / liberation from mechanical ventilation\] (maintained for at least 48 hours)\].

Organ Dysfunction - Heartbetween inclusion and 30 days later

Time to cessation of vasopressor support during ICU stay (The number of hours between enrollment and complete stopping of vasopressor support (defined as its complete interruption for at least 24 consecutive hours).

Organ Dysfunction - Renalbetween inclusion and 30 days later

Time to cessation of Renal Replacement during ICU stay \[The number of calendar days between start of renal replacement therapy and complete liberation from renal replacement therapy (at least 48 hours for continuous replacement modalities and 5 days for intermittent ones).

Organ Dysfunctionbetween inclusion and 5 days later

Variation of daily SOFA score.

Trial Locations

Locations (2)

Humanitas Research Hospital

🇮🇹

Milan, Italy

Humanitas Clinical and Research center

🇮🇹

Rozzano, Milan, Italy

Humanitas Research Hospital
🇮🇹Milan, Italy
Antonio Messina
Contact
+390282241
antonio.messina@humanitas.it
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