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CTRI Number  CTRI/2025/01/079271 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 13/05/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to find out how hospitals around the world are giving fluids to the patient through a tube in their vein and what practices they follow while giving fluids. We also want to find out how often patients get too much fluid while staying in the ICU and how doctors treat it. 
Scientific Title of Study   Fluid administration and fluid overload in the intensive care unit(FLUID-ICU)-an international inception cohort study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT06258616  ClinicalTrials.gov 
Project no 4514 Version 7.2 dated14.03.2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital, Mumbai 
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, Mumbai 
Address  Department of Anesthesia, Critical care and Pain, Main Building, Second Floor, 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 N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  Department of Anesthesia, Critical care and Pain, Main Building, Second Floor, Dr E Borges Road, Parel Mumbai


MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel, Mumbai, Maharshatra,India 400012 
 
Primary Sponsor  
Name  Copenhagen University Hospital,Denmark 
Address  Copenhagen University Hospital, North Zealand, Frederikssundsvej 30, 3600 Frederikssund, Denmark 04548295000 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Denmark
Finland
France
Germany
Greece
Hong Kong
India
Ireland
Italy
Netherlands
New Zealand
Norway
Poland
Qatar
Spain
Sweden
United Kingdom  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shilpushp Bhosale  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Navi Mumbai  Intensive Care Unit, 5th Floor, PPV bluilding, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre Plot No. 1& 2, Sector 22 Kharghar, Navi Mumbai - 410210
Mumbai (Suburban)
MAHARASHTRA 		 9619310657

shilbhosale@gmail.com 
Dr Divya Pal  Institute of Critical Care and Anesthesia Medanta The Medicity  Intensive Care Unit, Institute of Critical Care and Anesthesia, Medanta- The Medicity, Sector- 38, Gurugram, Haryana- 122001
Gurgaon
HARYANA 		 07827535203

divyapalarora@gmail.com 
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 		 9820156070

sheila150@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional Ethics Committee, Madras Medical College  Approved 
Institutional Ethics Committee, Yashoda Academyof Medical Educationand Research  Approved 
Medanta Institutional Ethics Committee  Approved 
Prakriya Hospital Institutional Ethics Committee  Approved 
Tata Memorial Hospital Institutional Ethics Committee-1  Approved 
Tata Memorial Hospital Institutional Ethics Committee-1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R69||Illness, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Adult patients- age more than or equal to 18 years of age
2) Acute admission to the ICU- patients admitted acutely to the participating ICUs due to acute or unexpected critical illness 
 
ExclusionCriteria 
Details  1) Patients previously included in the FLUID-ICU study
2) Patients with planned ICU admission.
3)Patients with major burns- Patients with acute burn injury of more than 10 percent of the body surface area leading to the present ICU admission. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number of patients with fluid overload  from study enrollment to ICU discharge or till day 28 whichever will be earlier 
 
Secondary Outcome  
Outcome  TimePoints 
Number of patients with fluid overload upon ICU admission-baseline  at the time of ICU admission 
Number of patients developing fluid overload during the ICU stay  from study enrollment to ICU discharge or till day 28 whichever will be earlier 
Number of days with fluid overload during the ICU stay  from study enrollment to ICU discharge or till day 28 whichever will be earlier 
Number of patients being treated with ‘active fluid removal’ such as use of diuretics, or renal replacement therapy  from study enrollment to ICU discharge or till day 28 whichever will be earlier 
Days alive without life-support within 28 days from ICU admission  till 28 days from ICU admission 
Days alive and out of hospital within 90 days from ICU admission  till 90 days from the date of ICU admission 
Mortality within 90 days from ICU admission  till 90 days from the date of ICU admission 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="50" 
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)   15/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/04/2024 
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)   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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [claramolinmolin@gmail.com].

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 31-07-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Study Title- Fluid administration and fluid overload in the intensive care unit (FLUID-ICU) -an international inception cohort study

What is the study about?

This study looks at how fluids are given to patients in the Intensive Care Unit (ICU) and whether too much fluid (called "fluid overload") can make patients sicker.

Why is this important?

Patients in the ICU often need fluids through an IV to help them stay hydrated and keep their blood pressure stable. But if they get too much fluid, it can cause problems like trouble breathing, kidney issues, and even increase the chance of dying.

What will the researchers do?

Researchers will collect information from many ICUs around the world. They will look at all the fluids given to adult patients who are suddenly admitted to the ICU over a 14-day period. They will gather data from medical records daily until the patient leaves the ICU or for up to 28 days.

What are the goals?

  1. Primary Goal: To find out how many patients in the ICU get fluid overload.
  2. Secondary Goals: To see how often fluids are removed from patients, how many days patients have fluid overload, how many days patients live without needing life support, how many days patients are out of the hospital, and the death rate within 90 days of being admitted to the ICU.

How will this help?

By understanding how fluids are managed in the ICU, doctors can improve the way they give fluids to patients. This can help prevent fluid overload and improve patient outcomes, potentially leading to better care practices in the future.

What are the risks?

This study is observational, which means researchers are just watching and recording what happens without changing any treatments. Therefore, it poses no risk or burden to the patients.

Ethical considerations:

The study will follow all ethical guidelines, ensure patient confidentiality, and obtain necessary approvals from ethical committees and authorities in each participating country.

Conclusion:

The findings from this study will provide important information on fluid management in ICUs worldwide and guide future research to improve patient care.

This summary provides an easy-to-understand overview of a complex medical study aimed at improving the care and outcomes of critically ill patients.

 
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