Fluid Challenge in Intensive Care The FENICE II Study

NCT06394947 | Completed

• 1 other identifier: FENICE II
• Study Type: observational
• Target: 4,734
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Illness; Septic Shock

Keywords

Fluid Therapy; Fluid Challenge; Fluid Bolus; Intensive Care; Hemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

• Composite of various aspects of fluid therapy

  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

  FIve days from ICU admission

Secondary Outcomes (8)

• 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

Other Outcomes (2)

• All aforementioned outcomes

  30 days from ICU admission

• All aforementioned outcomes

  30 days from ICU admission

Interventions

Fluid administration (any type) OTHER

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.

Also known as: Fluid Infusion, Fluid Bolus, Fluid Balance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive adult (≥18 years old) patients admitted to the intensive care unit and expected to stay at least 48h.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead
• European Society of Intensive Care Medicine: collaborator

Study Sites (2)

Humanitas Clinical and Research center

Rozzano, Milan, 20089, Italy

Location

Humanitas Research Hospital

Milan, Italy

Location

Related 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 inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11.

  PMID: 26162676 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Critical Illness; Shock, Septic

Interventions

Water-Electrolyte Balance

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Intervention Hierarchy (Ancestors)

Osmoregulation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Homeostasis; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: May 1, 2024
• Study Start: January 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

IT (2)