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CTRI Number  CTRI/2025/02/079900 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   An international observational study to describe the modality of fluid administration in Intensive Care Unit  
Scientific Title of Study   Fluid challenge in Intensive Care: a worldwide global inception cohort study. The FENICE II study. 
Trial Acronym  FENICE II study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical care and Pain, Main Building,Second Floor, Dr E Borges Road, Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical care and Pain, Main Building,Second Floor, Dr E Borges Road, Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical care and Pain, Main Building,Second Floor, Dr E Borges Road, Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel, Mumbai 400012 
 
Primary Sponsor  
Name  IRCCS Humanitas Research Hospital – 
Address  Rozzano (Milano), Italy 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Italy
Belgium
France
Ireland
Netherlands
Sweden
United Kingdom  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ziyokov Joshi  Tagore hospital and heart care centre Jalandhar  91, Mahavir Marg, Sangat Colony, Durga Colony, Jalandhar, Punjab 144008
Jalandhar
PUNJAB 
9814120766

drziyokovjoshi@yahoo.co.in 
Dr Sheila N Myatra  Tata Memorial Hospital, Mumbai  MB 101 and 201, Intensive Care Units, First and Second Floor, Main Building, Tata Memorial Hospital, Parel, Mumbai Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
9820156070

sheila150@hotmail.com 
Dr Manjaree Mishra  Trauma Centre, Institute of Medical Sciences, Banaras Hindu University  Samne Ghat Rd, opp. HP Petrol Pump, Bhagwanpur, Varanasi, Uttar Pradesh 221005
Varanasi
UTTAR PRADESH 
9988765775

mnajari@bhu.ac.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
Aster CMI Hospital Istitutional Ethics Committee  Approved 
Criticare Hospital and Research Institute Ethics Committee  Approved 
Ethics Committee of Amrita School of Medicine  Approved 
Institutional Ethics Commitee Care Hospitals  Approved 
Institutional Ethics Committe - Tagore Hospital and Heart care centree - Biomedical research   Approved 
INSTITUTIONAL ETHICS COMMITTEE - BIOMEDICAL RESEARCH  Approved 
Institutional Ethics Committee Asian Institute of Gastroenterology  Approved 
Institutional Ethics Committee Asian Institute of Medical Sciences  Approved 
Institutional Ethics Committee Institute of Medical Ssciences Institute of Medical Sciences Banaras Hindu University   Approved 
Institutional Ethics Committee Yashoda Academy of Medical Education and Research  Approved 
INSTITUTIONAL ETHICS COMMITTEE- CLINICAL RESEARCH & STUDIES ULTIMATE MEDICARE  Approved 
Integrity Ethics Committe Care CHL Hospital  Approved 
MOSC Medical College Institutional Ethics Committee  Approved 
Prakriya Hospital Institutional Ethics Committee  Approved 
Tata Memorial Hospital Institutional Ethics Committee-2  Approved 
Wockhardt Hospitals Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All consecutive adult patients admitted to ICU and expected to stay at least 48h 
 
ExclusionCriteria 
Details  Planned admission after surgery for overnight ICU stay
Refusal of consent
Moribund patients (i.e. expected survival less than 24h) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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 (i.e. FC and not FC).  At 5 days of ICU admission 
 
Secondary Outcome  
Outcome  TimePoints 
1. To explore any association between fluid administration characteristics & clinical outcomes
2. To evaluate factors potentially associated with the respective proportion of the different modalities of fluid administration
3. To characterize FC administration modality in a large cohort of ICU patients 
At 30 days of ICU admission 
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Introduction:
Fluids are the first line treatment of critically ill patients with shock aiming to increase venous return, stroke volume (SV) and, consequently, cardiac output (CO) and tissue oxygen delivery (DO2) [1-5]. Fluid administration is also one of the most disputed interventions in the treatment of critically ill patients [6, 7]. Even more debated is how to appraise and manage the response to fluid administration [1-6]. The optimal volume of fluids to be given in hypotensive patients with sepsis or in septic shock is still debated. The 2016 Surviving Sepsis Campaign (SSC) guidelines (SCC) strongly recommended giving at least 30 ml/kg of crystalloids for initial resuscitation of patients with sepsis-induced hypoperfusion [8]. This was downgraded to a weak recommendation in the 2021 update of the SSG due to a lack of prospective intervention studies comparing different volumes for initial resuscitation in sepsis or septic shock [9]. A recent randomized-controlled trial in patients with sepsis-induced hypoperfusion (averaged mortality of 14%) [10] and another in patients with septic shock (averaged mortality of 42%) [11], showed that a “restrictive” fluid strategy was non inferior to a “liberal” one.
From a physiological point of view, the goal of fluids is to increase SV and then CO and should only be given if the plateau of cardiac function is not reached in the individual patient (fluid responsiveness state). Fluid challenge (FC) is a diagnostic test consisting in the administration of a fixed volume of fluids with the purpose of identifying patients who will increase CO in response to fluid infusion [3, 12, 13]. Since several bedside clinical signs, systemic arterial pressure and static volumetric variables are poorly predictive of the effect of FC, the response to FC may be predicted at the bedside by using a functional hemodynamic test. This consists of a manoeuvre that affects cardiac function and/or heart-lung interactions, with a subsequent hemodynamic response, the extent of which varies between fluid responders and non-responders [14-16]. The combination of a functional hemodynamic test to assess fluid responsiveness and FCs to customize fluid infusion may be used to reduce the risk of fluid overload. Of note, at least 30% of the overall amount of fluid administered in septic patients may be related to the hidden and unintentional creep volume [17] (i.e. fluid administration not driven by a functional assessment of hemodynamics). In fact, a recent retrospective study on 14,654 patients during the cumulative 103,098 days showed that maintenance and replacement fluids accounted for 24.7% of the mean daily total fluid volume, thereby far exceeding resuscitation fluids (6.5%) and were the most important sources of sodium and chloride. Fluid creep represented a striking 32.6% of the mean daily total fluid volume [median 645 mL (IQR 308-1039 mL)] 
Unfortunately, neither the FC nor the use of functional hemodynamic test are standardised in current clinical practice [18-21]. This was confirmed by the FENICE study, a large observational study on 2,213 patients conducted by the European Society of Intensive Medicine (ESICM) [19]. Since the first FENICE study publication, many activities have been by provided by the ESICM in an effort to improve education and implementation of evidence-based haemodynamic management in intensive care unit (ICU) patients. These programs have focused on physiology, haemodynamic monitoring and interpretation, and fluid therapy. These efforts may have improved the use of functional hemodynamic tests and FC at bedside, with an impact on haemodynamic management and fluid administration policy in the ICU
Aims & Objectives:
The primary aim of the FENICE II study is to describe the modality of fluid administration in the acute phase of resuscitation from hemodynamic instability in ICU patients.
As secondary aims, we’ll appraise in-hospital, ICU and 30-day mortality and major organ dysfunction. Finally, we’ll assess the use of variables (including clinical signs of hypovolemia, and indexes/images obtained from hemodynamic monitoring or echography) and functional hemodynamic tests to guide FC infusion in ICU patients, and the modality of FC administration (i.e. volume, rate, type of fluid), of evaluation of fluid responsiveness at the bedside.
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.
 
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