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CTRI Number  CTRI/2025/04/084028 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Fluid therapy ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A randomised control trial that compares intravenous fluid therapy and ultrasonography guided fluid therapy in patients with severe infection. 
Scientific Title of Study   Fluid responsiveness between early goal directed fluid therapy and ultrasonography guided fluid resuscitation in septic shock patients : A randomized control trial 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  Sathi Dhar 
Designation  Post graduate trainee Anesthesiology  
Affiliation  Agartala Government Medical College. 
Address  3rd floor of new teaching hospital, Department of Anesthesiology, Agartala Government Medical College, P.O. Kunjaban, Agartala, West Tripura, Pin- 799006

West Tripura
TRIPURA
799006
India 
Phone  7085249539  
Fax    
Email  sathidhar035@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaskar Majumdar  
Designation  Associate Professor and incharge HOD in Department of Anesthesiology  
Affiliation  Agartala Government Medical College and GBP Hospital  
Address  3rd floor of new teaching hospital, Department of Anesthesiology, Agartala Government Medical College, P.O. Kunjaban, Agartala, West Tripura, Pin- 799006

West Tripura
TRIPURA
799006
India 
Phone  9436454137  
Fax    
Email  vaskarmajumdar100@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sathi Dhar 
Designation  Post graduate trainee Anesthesiology  
Affiliation  Agartala Government Medical College and GBP Hospital  
Address  3rd floor of new teaching hospital, Department of Anesthesiology, Agartala Government Medical College, P.O. Kunjaban, Agartala, West Tripura, Pin- 799006

West Tripura
TRIPURA
799006
India 
Phone  7085249539  
Fax    
Email  sathidhar035@gmail.com  
 
Source of Monetary or Material Support  
Agartala Government Medical College and GBP Hospital,Agartala Government Medical College, P.O. Kunjaban, Agartala, West Tripura, Pin- 799006 
 
Primary Sponsor  
Name  Agartala Government Medical College  
Address  Kunjaban, Agartala, West Tripura, Pin- 799006 
Type of Sponsor  Government medical college 
 
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 Sathi Dhar  Agartala Government Medical College and GBP Hospital   Department of Anesthesiology. 3rd floor of New Teaching Hospital,Vill- Kunjaban, P.O.- West Tripura, Pin- 799006, Agartala, Tripura
West Tripura
TRIPURA 		 7085249539

sathidhar035@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE OF AGARTALA GOVERNMENT MEDICAL COLLEGE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, (2) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, (3) ICD-10 Condition: A419||Sepsis, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fluid therapy   Early goal directed fluid therapy with 500 ml of crystalloid every 30 min till CVP 8-12 mmHg in one group. Ultrasonography guided fluid therapy by measuring diameter and collapsibility of inferior vena cava in another group. Mean arterial pressure, respiratory rate, urine output will be measured in both the group. 
Comparator Agent  Early goal directed fluid therapy Ultrasonography guided fluid therapy   Fluid admission with crystalloid 500 ml every 30 minutes in one group compared with ultrasonography guided fluid responsiveness by measuring inferior vena cava diameter and collapsibility. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  i) patients age more than 18 years and less than 65 years with a definitive diagnosis of septic shock.
ii) patients fulfilling two or more systemic inflammatory response syndrome criteria. 
 
ExclusionCriteria 
Details  i) pre-existing valvular or structural heart disease patients.
ii) known history of acute coronary syndrome, acute pulmonary edema.
iii) patients age less than 18 years and pregnant females
iv) patient under invasive mechanical ventilator  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
i)Mean arterial pressure, central venous pressure, heart rate, respiratory rate, urine output will be assessed.
ii) Inferior vena cava diameter and collapsibility will be assessed.
 		 i)Mean arterial pressure, central venous pressure, heart rate, respiratory rate, urine output will be assessed every 30 minutes upto 6 hours of admission.
ii) Inferior vena cava diameter and collapsibility will be assessed every 30 minutes upto 6 hours of admission.
 
 
Secondary Outcome  
Outcome  TimePoints 
1) To compare any signs and symptoms of fluid overload during study period   First 6 hours since admission  
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   01/05/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [sathidhar035@gmail.com].

  6. For how long will this data be available start date provided 23-09-2027 and end date provided 15-06-2034?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   a) To compare early goal directed fluid therapy with ultrasonography guided fluid responsiveness in septic shock patients admitted in Intensive Care Unit.
b) To compare hemodynamic variables in two groups during the study period 
c) To find out the proportion of patients developing fluid overload during study period.
 
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