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CTRI Number  CTRI/2025/04/085655 [Registered on: 25/04/2025] Trial Registered Prospectively
Last Modified On: 25/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparison of BIA with daily weight, intake-output with in sepsis and septic shock patients 
Scientific Title of Study   Prospective observational study to compare weight, BIA,Intake-output balance for cumulative fluid balance in sepsis and septic shock patients 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SAnjith Saseedharan 
Designation  Chief Intensivist and HOD critical care 
Affiliation  SL Raheja 
Address  3rd north ICU,Critical Care department,Sl Raheja Hospital,Raheja Rugnalaya Marg, Mahim West, Mahim, Mumbai, Maharashtra
3rd north ICU,Critical Care department,Sl Raheja Hospital,Raheja Rugnalaya Marg, Mahim West, Mahim, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400016
India 
Phone  9004479549  
Fax    
Email  docsanjith@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SAnjith Saseedharan 
Designation  Chief Intensivist and HOD critical care 
Affiliation  SL Raheja 
Address  3rd north ICU,Critical Care department,Sl Raheja Hospital,Raheja Rugnalaya Marg, Mahim West, Mahim, Mumbai, Maharashtra
3rd north ICU,Critical Care department,Sl Raheja Hospital,Raheja Rugnalaya Marg, Mahim West, Mahim, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400016
India 
Phone  9004479549  
Fax    
Email  docsanjith@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SAnjith Saseedharan 
Designation  Chief Intensivist and HOD critical care 
Affiliation  SL Raheja 
Address  3rd north ICU,Critical Care department,Sl Raheja Hospital,Raheja Rugnalaya Marg, Mahim West, Mahim, Mumbai, Maharashtra
3rd north ICU,Critical Care department,Sl Raheja Hospital,Raheja Rugnalaya Marg, Mahim West, Mahim, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400016
India 
Phone  9004479549  
Fax    
Email  docsanjith@rediffmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Sanjith Saseedharan 
Address  Raheja Rugnalaya Marg, Mahim West, Mahim, Mumbai, Maharashtra 400016 
Type of Sponsor  Other [Self] 
 
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 
Dr Sanjith Saseedharan  SL Raheja  ICCU ,Critical Care department,Sl Raheja Hospital,Raheja Rugnalaya Marg, Mahim West, Mahim, Mumbai, Maharashtra
Mumbai
MAHARASHTRA 
9004479549

docsanjith@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: B955||Unspecified streptococcus as the cause of diseases classified elsewhere,  
 
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  Any patients with sepsis and or septic shock requiring ionotropic supports 
 
ExclusionCriteria 
Details  CKD patients
Amputee
Trauma patients
Post op or surgical patients
Patient with LV dysfunction 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Compare BIA with daily weight and intake output for cumulative fluid balance in sepsis and septic shock  6months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   07/05/2025 
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  
Fluid resuscitation is essential component of sepsis bundle, initial fluid resuscitation can increase the stroke volume and restore organ perfusion. However, excess fluid thereafter may damage vascular integrity leading to tissue demand organ dysfunction. Cumulative fluid balance (CFB) is total amount of fluid accumulates in body over a period of time. High CFB can increase time on mechanical ventilator, length of ICU stays and mortality.
There are various surrogate markers for CFB (e.g.-Daily weight, calculated fluid balance, clinical assessment of edema, skin turgor, lung edema, thirst, CVP) but its less subjective, poorly validated.
Bioimpedance analysis (BIA) along with calculated fluid balance, daily weight measurement will help in maintaining CFB. Calculated fluid balance is most easy, feasible and vastly used method. Intake -output calculation is considered as gold standard for CFB, but it doesn’t measure insensible loss. Daily weight measurement in ICU patient is tedious task, less precise. BIA measures electrical impedance by passing weak and small alternating current through body. It not only calculates total body water (TBW) but Intracellular weight (ICW) and Extracellular water (ECW) as well. Hence, the need to assess merit of BIA against the above parameters
 
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