| 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
|
|
|
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
|
|
|
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. |