| 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
|
|
|
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
|
|
|
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. |