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
|
|
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
|
|
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
|
|
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 |