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CTRI Number  CTRI/2024/06/068806 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to evaluate the practice of Fluid Therapy in very sick patients on mechanical ventilator  
Scientific Title of Study   Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)– an international multicenter observational cohort study 
Trial Acronym  PRoFLUID 
Secondary IDs if Any  
Secondary ID  Identifier 
4390_Version 2.0 dated 04.04.2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheila Nainan Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia Critical care and Pain Tata Memorial Centre 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 Nainan Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia Critical care and Pain Tata Memorial Centre Dr E Borges Road Parel Mumbai


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


MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Mumbai 400012 
 
Primary Sponsor  
Name  Amsterdam University Medical Centers, location ‘AMC’ 
Address  Department of Intensive Care Amsterdam University Medical Centers, location ‘AMC’ Meibergdreef 9 1105 AZ Amsterdam The Netherlands 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Netherlands
India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharat Kumar Pamulapati  Citizens Specialty Hospital  1-100/1/CCH, Nallagandla Village, Serilingampally Mandal, Hyderabad 500019
Hyderabad
TELANGANA 		 4067191919

bharathpamulapati@gmail.com 
Dr Jagadeesh K N  Medanta, The Medicity  Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA 		 9899799314

drknjagadeesh@hotmail.com 
Dr Rekha Das  Shanti Memorial Hospital  Thoria Sahi Patnaik Colony, Mangalabag, Cuttack, Odisha 753001
Cuttack
ORISSA 		 0671-2415250

rekhadas2003@yahoo.in 
Dr Ziyokov Joshi  Tagore Hospital and Heart Care Centre Pvt Ltd  Banda Bahadur Nagar, Mahavir Marg, Jalandhar, Punjab, 144008
Jalandhar
PUNJAB 		 0181468700

drziyokovjoshi@yahoo.co.in 
Dr Sheila Nainan Myatra  Tata Memorial Hospital  Department of Anesthesia Critical care and Pain, Second floor, Major OT complex, Main Building, Tata Memorial Centre Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA 		 9820156070

sheila150@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Citizens Institutional Ethics commitee  Approved 
Citizens Institutional Ethics Committee  Approved 
Ethics Committee Shanti Hospital  Approved 
Institutional Ethics Committee l, Tata Memorial Hospital  Approved 
Institutional Ethics Committee- Biomedical Research, Tagore Hospital and Heart Care Centre Pvt Ltd  Approved 
Medanta Institutional Ethics Committee  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  NA 
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. admitted to a participating ICU
2. receiving invasive ventilation within 3 days of ICU admission and
3. duration of ventilation more than 24 hours 
 
ExclusionCriteria 
Details  1. Age less than 18 years
2. patients transferred under invasive ventilation from another ICU 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is a composite of various aspects of fluid therapy, including total
volumes of types of fluids administered in the first three days after start of invasive
ventilation and total volume of fluids infused in the first seven days after start of invasive ventilation. 		 At day 3 and day 7 of start of invasive ventilation in ICU 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes include timing of start, type, and duration of continuous administration of vasopressors; timing of start, infusion time and types of administered diuretics; daily urine output and cumulative fluid balances; and typical ICU outcomes, like duration of ventilation, lengths of stay in ICU and hospital, and mortality in the ICU and hospital.  At day 28, 60 and 90 
 
Target Sample Size   Total Sample Size="2500"
Sample Size from India="20" 
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)   24/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/06/2024 
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)   Not Yet Recruiting 
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   Rationale 
The worldwide practice of fluid and vasopressor therapy in critically ill invasively ventilated patients is uncertain. Indeed, it is unclear whether there is a difference in fluid and vasopressor therapy in these patients between Low– and Middle–income Countries (LMICs) and High–income Countries (HICs). 

Objective 
To determine various aspects of fluid and vasopressor therapy in critically ill invasively ventilated patients in LMICs and HICs. 

Hypothesis 
There is substantial worldwide variation in practice of fluid and vasopressor therapy in critically ill invasively ventilated patients

Study design 
International, multicenter, observational study in critically ill invasively ventilated patients; data are captured during a predefined period per geographic region or country. 

Study population 
Critically ill invasively ventilated patients.

Main study parameter/endpoint 
The primary outcome is a composite of various aspects of fluid therapy, including total volumes of types of fluids administered in the first three days after start of invasive ventilation and total volume of fluids infused in the first seven days after start of invasive ventilation. Secondary outcomes include timing of start, type, and duration of continuous administration of vasopressors; timing of start, infusion time and types of administered diuretics; daily urine output and cumulative fluid balances; and typical ICU outcomes, like duration of ventilation, lengths of stay in ICU and hospital, and mortality in the ICU and hospital, and at day–28, –60 and –90.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness 
Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts or electronic medical records systems is of no risk to the patients.
 
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