Exploring fluid administration in critically ill patients in the ICU
Fluid Challenge in Intensive Care: a Worldwide Global Inception Cohort Study: The FENICE II Study
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 type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Humanitas Clinical and Research Center Academic / other |
| Locations | 2 sites (Rozzano, Milan and 1 other locations) |
| Trial ID | NCT06394947 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rozzano, Milan and 1 other locations
- Humanitas Clinical and Research center — Rozzano, Milan, Italy (Not_yet_recruiting)
- Humanitas Research Hospital — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Maurizio Cecconi, Prof
- Email: maurizio.cecconi@humanitas.it
- Phone: +390282241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.