| 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
|
|
|
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
|
|
|
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
|
|
|
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. |