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CTRI Number  CTRI/2025/09/095470 [Registered on: 30/09/2025] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Longitudinal Study 
Study Design  Single Arm Study 
Public Title of Study   Using Heart Ultrasound to Predict Outcomes in Patients with Sepsis on Ventilator Support 
Scientific Title of Study   Utility of Transthoracic Echocardiography as predictor of outcomes in patients with sepsis on invasive mechanical ventilation: A Prospective Longitudinal 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  Kajal R Shetty 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education 
Address  Department of Critical care, Kasturba Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8073814280  
Fax    
Email  kajal.shetty@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Souvik Chaudhuri  
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education 
Address  Department of Critical Care, Kasturba Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9937178620  
Fax    
Email  souvik.chaudhuri@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Kajal R Shetty 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education 
Address  Department of Critical Care, Kasturba Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8073814280  
Fax    
Email  kajal.shetty@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal Academy of Higher Education, Mangalore, Karnataka, India 
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India 
 
Primary Sponsor  
Name  Kajal R Shetty 
Address  Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India - 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kajal R Shetty  Kasturba Medical College  Department of Critical Care, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 
8073814280

kajal.shetty@manipal.edu 
Kajal R Shetty  Kasturba Medical College  Department of Critical Care, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education
Dakshina Kannada
KARNATAKA 
8073814280

kajal.shetty@manipal.edu 
 
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: B998||Other infectious disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients more than 18 years with sepsis on invasive mechanical ventilation 
 
ExclusionCriteria 
Details  Patients where 24 hours have passed after sepsis diagnosis
Pregnant patients
Patients with prior mitral or aortic valvular regurgitation
Patients with prosthetic heart valves
Patients with cardiac transplant
Patients having tachyarrhythmias (HR more than 150/min).
Patients with pericardial tamponade or large pericardial effusion more than 20 mm between LV & RV
Patients with known/previous MI or cardiomyopathies with EF less than 40%
Patients with known/previous PAH
Chronic kidney diseases
Chronic liver diseases
Poor echo window 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
28-day in-hospital mortality  28-day in-hospital mortality 
 
Secondary Outcome  
Outcome  TimePoints 
ICU mortality  The time period of patients in the ICU  
Prolonged length of ICU stay among survivors  More than and equal to 14 days 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   15/10/2025 
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="4"
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 - NO
Brief Summary  

Sepsis remains a major cause of morbidity and mortality among critically ill patients. Sepsis-induced cardiac dysfunction is common and associated with poor outcomes, but the prognostic value of specific transthoracic echocardiography (TTE) parameters in this setting is not well established.

This prospective longitudinal study aims to identify echocardiographic parameters that can reliably predict ICU and hospital outcomes in adult patients with sepsis requiring invasive mechanical ventilation. A total of 300 patients aged 18–80 years, diagnosed with sepsis as per Sepsis-3 criteria, will be recruited from intensive care units at Kasturba Medical College Hospitals, Manipal and Mangalore.

TTE will be performed on Day 1 and Day 3 of sepsis diagnosis to assess left and right ventricular function, hemodynamic parameters, and lung/renal ultrasound indices. Clinical data, biomarkers, and outcomes including 28-day in-hospital mortality, ICU mortality, prolonged ICU stay, and hospital readmission within 6 months will be recorded. The study will also characterize echocardiographic and POCUS parameters corresponding to sepsis-induced acute respiratory failure phenotypes (A–D).

The findings are expected to identify specific TTE parameters predictive of adverse outcomes in sepsis, support phenotype-based risk stratification, and contribute to improved prognostication and clinical decision-making in critically ill patients.

 
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