Fluid Challenge in Intensive Care The FENICE II Study

Critical Illness Clinical Trial

— FENICE II  

Official title:

Fluid Challenge in Intensive Care: a Worldwide Global Inception Cohort Study: The FENICE II Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06394947
• Other study ID #: FENICE II
• Status: Not yet recruiting
• Start date: January 1, 2025
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Humanitas Clinical and Research Center
• Contact: Maurizio Cecconi, Prof
• Phone: +390282241
• Email: maurizio.cecconi[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Septic Shock

Intervention

Other:
• Fluid administration (any type)
The fluid challenge (FC) (bolus) is defined as the administration of any bolus of fluid (crystalloid or colloid) which is expected to affect pressure/flow/perfusion variables. The FC is expected to be completed within 30 min.

Locations

Country	Name	City	State
Italy	Humanitas Clinical and Research center	Rozzano	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Humanitas Clinical and Research Center	European Society of Intensive Care Medicine

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid Administration	To describe the modality of fluid administration	Up to 5 days from ICU admission
Primary	Association between fluid administration characteristics and clinical outcomes	Types of fluids used	Up to 30 days from ICU admission
Primary	Boluses and not Boluses	Proportion of the different modalities of fluid administration	Up to 5 days from ICU admission
Primary	Fluid Challenge	Modality of Fluid Challenge Administration	Up to 5 days from ICU admission
Secondary	In-hospital mortality	Mortality during Hospital stay	Up to 30 days from ICU admission
Secondary	ICU mortality	Mortality during ICU stay	Up to 30 days from ICU admission
Secondary	Alive without any organ support	Number of calendar days between inclusion and 28 days that the patient is alive and with no requirement of cardiovascular, respiratory and renal support.	between inclusion and 30 days later
Secondary	Organ Dysfunction - Lung	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, including non-invasive mechanical ventilation (maintained for at least 48 hours)].	between inclusion and 30 days later
Secondary	Organ Dysfunction - Lung	Mechanical ventilation support-free days free days from day 1 to day 28. Cessation of mechanical ventilation support implies its complete interruption for at least 24 consecutive hours)	between inclusion and 30 days later
Secondary	Organ Dysfunction - Lung	Ventilation Associated Pneumonia (VAP) cumulative incidence (number of VAP per patient) and rate (number of VAP per 1000 days of MV)	between inclusion and 30 days later
Secondary	Organ Dysfunction - Heart	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).	between inclusion and 30 days later
Secondary	Organ Dysfunction - Heart	Vasopressor support-free days during ICU stay from day 1 to day 28. Cessation of vasopressor support implies its complete interruption for at least 24 consecutive hours)	between inclusion and 30 days later
Secondary	Organ Dysfunction - Heart	Inotropes support free days during ICU stay	between inclusion and 30 days later
Secondary	Organ Dysfunction - Renal	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).	between inclusion and 30 days later
Secondary	Organ Dysfunction - Renal	Renal Replacement support-free days during ICU stay from day 1 to day 28. Cessation of Renal Replacement support implies its complete interruption at least 48 hours for continuous replacement modalities and 5 days for intermittent ones)	between inclusion and 30 days later
Secondary	Organ Dysfunction - Renal	Variation of creatinine-based KDIGO stage (Time Frame: 7 days after ICU admission). Renal function assessed according to KDIGO staging system from randomization through day 7 to assess for "de novo" or "worsening" acute kidney injury. Patients under chronic renal replacement therapy will not meet this end-point	between inclusion and 30 days later

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