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CTRI Number  CTRI/2024/10/076066 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Other 
Public Title of Study   Impact of total fluid balance in patients with mechanical ventilator support admitted to Intensive Care Unit 
Scientific Title of Study   Association between cumulative balance and extubation failure in multi-disciplinary intensive care unit, a prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Blessy 
Designation  Post Graduate student 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai.

Chennai
TAMIL NADU
600116
India 
Phone  7397647382  
Fax    
Email  blsy2721@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Velumuragn selvam 
Designation  Associate professor 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai.

Chennai
TAMIL NADU
600116
India 
Phone  9968859560  
Fax    
Email  dr.velsri86@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MK Renuka 
Designation  Professor and Head Of Department 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai.

Chennai
TAMIL NADU
600116
India 
Phone  8056126336  
Fax    
Email  renuka.mk@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research  
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Blessy  Sri Ramachandra Institute Of Higher Education and Research  Department of Critical Care Medicine, Sri Ramachandra Institute Of Higher Education and Research, Porur, Chennai
Chennai
TAMIL NADU 
7397647382

blsy2721@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients above 18 years of age
Patients receiving invasive ventilation more than 24 hours
After successful completion of SBT
 
 
ExclusionCriteria 
Details  Patients below 18 years of age
Patients who are already extubated
Mechanically ventilated for less than 24 hours
Pregnancy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify the impact of cumulative fluid balance in relation to extubation.  Six months 
 
Secondary Outcome  
Outcome  TimePoints 
To analyze the baseline parameters associated with extubation.  Six months 
 
Target Sample Size   Total Sample Size="60"
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)   02/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

A positive cumulative fluid balance is known to be associated with increased mortality in critically ill patients. Studies have shown favorable clinical outcomes by achieving negative fluid balance in the later stage of critical illness. There is a strong biological plausibility to believe that the cumulative fluid balance will have its impact on the respiratory outcome of patients. A positive cumulative fluid balance leads to increased capillary leak, increase in extravascular lung water, and decrease in lung compliance and may result in respiratory failure both during spontaneous breathing trial (SBT) and in the immediate post extubation period. Restrictive fluid strategy has shown to decrease the length of mechanical ventilation, intensive care unit (ICU) length of stay, and a trend toward decreased mortality in patients with acute respiratory distress syndrome. In an earlier study, the relationship between fluid balance and weaning outcome was explored. Both negative fluid balance 24‑h pre-extubation and negative net cumulative balance since intubation were found to be independently associated with successful weaning. However, extensive use of diuretics in the study population and majority of patients achieving negative fluid balance or euvolemia at the first SBT questions the generalizability of the study results.

 
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