News: Closure of the eCRF platform:
The Fenice REDCap dataset permanently closed on December 31st, 2025. It is no longer possible to include or validate patient data.
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FENICE II Study Launched on January 13th, 2025
Dear Colleagues,
The FENICE II study has officially begun on 13 January 2025. The eCRF platform closed on 31 December 2025. The study focuses on fluid management in critically ill ICU patients.
More than 200 ICUs took part from around the world.
Thank you for being part of this initiative. Together, we will make a lasting impact on critical care worldwide!
Maurizio Cecconi – FENICE II study PI
Antonio Messina – FENICE II study CO-PI
What is the modality of fluid administration in ICU patients worldwide and what is the impact of fluid administration on clinical outcomes?
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.
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 haemodynamic tests to guide bolus infusion.
Prospective multicentre worldwide study.
Inclusion criteria:
Exclusion criteria:
Enrollment and study periods: We have two data collection periods to choose from:
The phase of centers enrolment was conducted over a time window of 12 months starting from 1st January 2024.
The phase of patients’ enrolment will be conducted over a two-weeks period (14 days), chosen within a time window of 6 months starting from 1st January 2025.
The study period for data collection regarding the modality of fluid administration that was considered was the first 5 days from ICU admission (ICU days 1-5).
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:
Clinical outcomes:
Functional outcomes:
Net daily fluid balance within 5 days.
All data generated in participating centres were systematically recorded using the study management software RedCap (Research Electronic Data Capture) and uploaded through a secure connection to an encrypted database in Humanitas Research Hospital (Milan, Italy) servers.
The enrollment phase of the study spun a two-week period during 2025. This time frame followed a preliminary period dedicated to trial dissemination and the recruitment of participating centres. Data collection regarding the modality of fluid administration focused on the first 5 days of ICU admission.
The study was based on descriptive variables from routine available data and did not affect treatment or handling of the patients included (observational study).
Centres’ coordinators and site investigators will be acknowledged either on the front page or under the group authorship (“FENICE II Study Group”) with the specific order determined by factors such as the number of included patients per study site, overall commitments, and centres’ recruitment. For multiple coordinators and/or investigators, authorship criteria will be evaluated at the end of study by the Steering Committee.
Ethics committee and appropriate local regulatory approvals had to be obtained by each investigator prior to enrolling patients. Each centre is responsible for ethical approval and approval and patient consent.
All data is anonymised and cannot be linked to individual subjects. The data is stored securely and all procedures regarding data management will comply with General Data Protection Regulation (GDPR) 2016/679/EU. The eCRF platform is licensed from RedCap and administered by RCCS Humanitas Research Hospital.
According to the ICH Guidelines on Good Clinical Practice the sponsor of a study (the Institution, should the investigator or study coordinator act as sponsor in the performance of her/his institutional duties under the employment or collaboration agreement with Humanitas) is the owner of the data resulting therefrom. All centres and investigators participating in the study should be made aware of such circumstance and invited not to disseminate information or data without the Institution’s prior express consent.
There is no financial compensation for participation. Participation in the study is completely voluntary.
Participation is now closed. It was done via national coordinators (see list hereunder).
Centers were supported by national coordinators and SC members regarding EC submission process, according to local regulations
Investgators could contact their national coordinator(s) if needed for ethical approval: (see list hereunder).
Principal Investigator: Pr Maurizio Cecconi MD, PhD
Co-Principal investigator: Dr Antonio Messina, MD PhD
Elie Azoulay, Maurizio Cecconi, Michelle Chew, Michael Darmon, Daniel De Backer, Lennie Derde, Jan De Waele, Katia Donadello, Ignacio Martin-Loeches, Antonio Messina, Xavier Monnet, Marlies Ostermann, Jean-Louis Teboul.
Please read Frequently Asked Questions (FAQs) document (soon available).
You can contact Antonio Messina at [mess81rc@gmail.com]
ESICM office: [research@esicm.org]
PRS number: NCT06394947
