Clinical trial No longer in our active list Observational Ages 18 and up

Exploring fluid administration in critically ill patients in the ICU

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

Run by Humanitas Clinical and Research Center · NCT06394947 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study looks at how fluids are given to critically ill patients in the ICU during their first five days to see how it affects their recovery.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment10000 (estimated)
SponsorHumanitas Clinical and Research Center
Academic / other
Locations2 sites (Rozzano, Milan and 1 other locations)
Trial IDNCT06394947 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adult patients aged 18 and older who are admitted to the ICU and expected to stay for at least 48 hours.

Probably not a fit

Patients who are moribund with an expected survival of less than 24 hours or those admitted for planned overnight ICU stays may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to provide a comprehensive description of fluid administration modalities during the first five days of ICU admission for critically ill patients. It will assess the overall fluid balance, characteristics of the fluids given, and the modalities of fluid administration. Additionally, the study will explore associations between fluid administration characteristics and clinical outcomes, utilizing statistical analyses to identify patterns and relationships. The findings will help understand current practices and their impact on patient outcomes in intensive care settings.

Why it matters

Potential benefit: If successful, this study could improve fluid management strategies in critically ill patients, potentially enhancing their recovery and outcomes.

How similar studies have gone: Previous studies, including the original FENICE study, have highlighted variability in fluid administration practices, indicating that this area of research is both relevant and necessary for improving patient care.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

  • Humanitas Research Hospital
    Milan, Italy
    Recruiting
  • Humanitas Clinical and Research center
    Rozzano, Milan, Italy
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.