FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/100622 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Bedside Echocardiography for Cardiac Assessment and Management in Septic Shock 
Scientific Title of Study   Role of bedside echocardiography in cardiac function evaluation and treatment planning in 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  ARUL NIVI P 
Designation  POST GRADUATE  
Affiliation  VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS  
Address  Room 100, Department Of Emergency Medicine,Vinayaka missions kirupananda variyar medical college and hospitals, chinnaseeragapadi salem
Vinayaka missions kirupananda variyar medical college and hospitals, chinnaseeragapadi salem
Salem
TAMIL NADU
636308
India 
Phone  9159756700  
Fax    
Email  arulnivi1110@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  ARUL NIVI P 
Designation  POST GRADUATE  
Affiliation  VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS  
Address  Room 100, Department Of Emergency Medicine,Vinayaka missions kirupananda variyar medical college and hospitals, chinnaseeragapadi salem
vinayaka missions kirupananda variyar medical college and hospitals, chinnaseeragapadi salem
Salem
TAMIL NADU
636308
India 
Phone  9159756700  
Fax    
Email  arulnivi1110@gmail.com   
 
Details of Contact Person
Public Query
 
Name  ARUL NIVI P 
Designation  POST GRADUATE  
Affiliation  VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS  
Address  Room 100, Department Of Emergency Medicine,Vinayaka missions kirupananda variyar medical college and hospitals, chinnaseeragapadi salem
vinayaka missions kirupananda variyar medical college and hospitals, chinnaseeragapadi salem
Salem
TAMIL NADU
636308
India 
Phone  9159756700  
Fax    
Email  arulnivi1110@gmail.com   
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  ARUL NIVI P 
Address  VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS, CHINNASEERAGAPADI, SALEM 
Type of Sponsor  Private 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 ARUL NIVI P  VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS   vinayaka missions kirupananda variyar medical college and hospitals, salem
Salem
TAMIL NADU 
09159756700

arulnivi1110@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: B999||Unspecified infectious disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients age group of 18 to 70 years with sepsis having a transthoracic echocardiographic examination performed within 24 hrs of the onset of septic shock in the Department of Emergency Medicine VMKVMCH 
 
ExclusionCriteria 
Details  Patient excluded if they had known pre-existing non-sepsis related cardiovascular compromise
such as acute myocardial infarction, cardiogenic
shock or a history of congestive heart failure with a left ventricle ejection fraction (LVEF) less than 40%; had a requirement for extracorporeal membrane oxygenation or a ventricular assist device
Developed septic shock at an outside hospital where patient managed with vasopressor and intrav nous fluid prior to transfer. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study strongly supports that the positive
fluid balance and impaired cardiac function are key predictors of mortality in septic shock. While initial fluid resuscitation is essential, ongoing fluid management should be guided by cardiac function and individual patient response. Future observational and interventional studies should explore fluid management strategies integrated with real-time cardiac function assessment to further improve outcomes in septic shock 
Fluid balance and Echocardiographic findings calulated at time interval of 24,48 and 72hr 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   26/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/01/2026 
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)   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  

Role of Bedside Echocardiography in Cardiac Function Evaluation and Treatment Planning in Septic Shock Patients

Septic shock is associated with significant cardiovascular dysfunction, including myocardial depression, altered preload, and abnormal vasoplegia, all of which contribute to high morbidity and mortality. Conventional clinical assessment and static hemodynamic parameters often fail to accurately identify the underlying cardiac abnormalities in these patients. Bedside echocardiography is a non-invasive, rapid, and repeatable tool that allows real-time assessment of cardiac structure and function, including left and right ventricular performance, volume status, and response to fluid resuscitation and vasoactive therapy.

This study aims to evaluate the role of bedside echocardiography in assessing cardiac function in patients with septic shock and its impact on guiding individualized treatment strategies. Echocardiographic parameters such as ventricular systolic function, chamber dimensions, inferior vena cava variability, and cardiac output will be assessed and correlated with therapeutic decisions, including fluid management and choice of vasoactive agents. The findings may help optimize hemodynamic management, prevent inappropriate fluid administration, and improve clinical outcomes in septic shock patients.

 
Close