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CTRI Number  CTRI/2025/01/079641 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To see the changes in heart function in patient with sepsis and fall back in blood pressure. 
Scientific Title of Study   Role of mitral annular plane systolic excursion and e- point septal separation for evaluation of left ventricular systolic dysfunction in patients with septic shock. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anuradha Gajraj 
Designation  DrNB SS Resident  
Affiliation  Holy Family Hospital 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road New Delhi

South
DELHI
110025
India 
Phone  8901573583  
Fax    
Email  gajraj.anuradha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ruchi Gupta 
Designation  Consultant 
Affiliation  Holy Family Hospital 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road New Delhi

South
DELHI
110025
India 
Phone  09910695602  
Fax    
Email  ruchi_gupta.mamc@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sumit Ray 
Designation  Senior Consultant & Head of the Department 
Affiliation  Holy Family Hospital 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road New Delhi
Holy Family Hospital
South
DELHI
110025
India 
Phone  09810614433  
Fax    
Email  drsray67@yahoo.co.in  
 
Source of Monetary or Material Support  
Holy Family Hospital Okhla Road New Delhi-110025 India 
 
Primary Sponsor  
Name  Dr Anuradha Gajraj 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road New Delhi-11025 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Anuradha Gajraj  Holy Family Hospital  Department of Critical Care Medicine Holy Family Hospital Okhla Road New Delhi
South
DELHI 		 8901573583

gajraj.anuradha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Holy Family Hospital Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A418||Other specified sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age more than or equal to 18 years of age admitted with sepsis in ICU meeting Sepsis 3.0 criteria.
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
For clinical operationalization, organ dysfunction will be represented by an increase in the Sequential (Sepsis-related) Organ Failure Assessment (SOFA) score of 2 points or more.

Patients with septic shock can be clinically identified by
1.vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater
2.serum lactate level greater than 2 mmol per litre (more than 18 mg per dL) in the absence of hypovolemia.


 
 
ExclusionCriteria 
Details  1. Moderate to severe mitral or aortic valvulopathy
2. Prosthetic valves
3. Significant arrythmias
4. Pregnant patient
5. Inadequate ECHO image quality
6. Not willing for consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To analyze MAPSE for identifying patients with left
ventricular systolic dysfunction denoted by LVEF less than 50%, an absolute GLS lesser than 17% or both. 		 Within 24hrs of Presentation 
 
Secondary Outcome  
Outcome  TimePoints 
To analyze EPSS for identifying patients with left
ventricular systolic dysfunction denoted by LVEF less than 50%, an absolute GLS lesser than 17% or both. 		 Within 24hrs of Presentation 
Comparing MAPSE and EPSS in identifying left ventricular systolic dysfunction
in septic shock patients. 		 Within 24hrs or presentation 
 
Target Sample Size   Total Sample Size="131"
Sample Size from India="131" 
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)   03/02/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This study is prospective, observational, cohort study which will be conducted in the critical care department at Holy Family Hospital, New Delhi to evaluate accuracy of MAPSE and EPSS for prediction of left ventricular systolic dysfunction in septic shock using point of care ultrasound. Patients above or equal the age of 18 years old admitted with septic shock after satisfying the eligibility criteria and willing to participate in the study will be recruited after obtaining written informed consent. After collecting the demographic information and diagnosis, patients in septic shock will be resuscitated in accordance with the hospital protocol and as per the dynamic markers of fluid resuscitation. Bedside echocardiography will be done after adequate fluid resuscitation within 24 hours of presentation by two different operators to know the contractility of heart and findings will be noted. No intervention shall be done for study. Data regarding the investigation reports and patient outcome will be recorded form ICU charts. The study aims to see how well MAPSE and EPSS correlate with LVEF and GLS in detecting left ventricular dysfunction, making them reliable and faster alternatives for critical care assessments. 
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