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CTRI Number  CTRI/2025/08/092724 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   Using a Special Heart Ultrasound to Detect Heart Problems in People with Sepsis or Septic Shock 
Scientific Title of Study   Role of Speckle tracking echocardiography in patients with sepsis and septic shock: A case control 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  Mohit 
Designation  DM Senior Resident  
Affiliation  ESIC Medical College and Hospital, Faridabad 
Address  Department of Critical Care Medicine(CCM),ESIC Medical College and Hospital, Faridabad, Haryana

Faridabad
HARYANA
121001
India 
Phone  8791756623  
Fax    
Email  mohit.narwal12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Harish Chander Sachdeva  
Designation  Professor Critical Care Medicine(CCM) 
Affiliation  ESIC Medical College and Hospital, Faridabad 
Address  Department of Critical Care Medicine(CCM),ESIC Medical College and Hospital, Faridabad, Haryana

Faridabad
HARYANA
121001
India 
Phone  9868159563  
Fax    
Email  sachdeva_hc04@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Yashita Joshi 
Designation  DM Senior Resident  
Affiliation  ESIC Medical College and Hospital, Faridabad 
Address  Department of Critical Care Medicine(CCM),ESIC Medical College and Hospital, Faridabad, Haryana

Faridabad
HARYANA
121001
India 
Phone  9897911206  
Fax    
Email  yashita201095@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical College and Hospital, NIT3 Faridabad Haryana121001 
 
Primary Sponsor  
Name  ESIC Medical College and Hospital, Faridabad 
Address  NIT-3 Faridabad, HARYANA 
Type of Sponsor  Government 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 Mohit   ESIC Medical College and Hospital Faridabad  Department of Critical Care Medicine ESIC Medical College and Hospital
Faridabad
HARYANA 
8791756623

mohit.narwal12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe ESIC Medical College and Hospital Faridabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Newly diagnosed cases of sepsis and septic shock as per sepsis 3 definition
2.Age 18-60 years

 
 
ExclusionCriteria 
Details  1.Use of inotropes and vasopressors 24hrs prior to ICU admission
2.Insufficient echocardiographic image quality
3.Patient or relatives declining participation
4.Prescence of acute myocardial infarction, myocarditis and cardiac arrythmia
5.Post -cardiopulmonary resuscitation
6.Previous history of congenital heart disease, valvular heart disease, cardiomyopathy, and chronic heart failure
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To measure the LV global longitudinal strain (GLS) and RV strain using 2D speckle-tracking echocardiography and classify the degree of myocardial impairment in both sepsis and septic shock patients.
2.To assess left ventricular (LV) and right ventricular (RV) function in patients with sepsis and septic shock using conventional echocardiographic parameters within 24 hours of ICU admission and at the time of recovery.
 
Within 24 hours , at 72 hours and at 7 days or at recovery
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the reversibility of cardiac dysfunction in septic shock patients by performing a follow-up echocardiography at recovery (defined as discontinuation of inotropes or vasopressors).  Within 24 hours , at 72 hours and at 7 days or at recovery 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   19/08/2025 
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="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  

All patients admitted to the Intensive Care Unit in the Department of Critical Care Medicine at ESIC Medical College Faridabad will be screened for sepsis in accordance with the Sepsis 3 definition. Screening will occur either at the time of admission or within twenty four hours prior to ICU admission to determine eligibility for the study.

The patients will be retrospectively divided into two groups. The study group will consist of patients diagnosed with septic shock. The control group will include patients with sepsis who did not develop septic shock. Both groups will be matched for age and sex in order to minimize bias and allow accurate comparisons.

Each enrolled patient will undergo a detailed clinical history and physical examination. Baseline clinical data will be recorded, including age, gender, presence of comorbidities, hemodynamic parameters, vasopressor requirements, and severity scores such as the Sequential Organ Failure Assessment score and the Acute Physiology and Chronic Health Evaluation II score. These parameters will be documented on the day of ICU admission.

The probable source of infection will be determined using appropriate culture techniques including analysis of sputum, blood, urine, cerebrospinal fluid, and serous body fluids. All patients will undergo both routine laboratory investigations and specific tests as clinically indicated.

Echocardiographic assessments will be conducted at defined time points. In the study group of patients with septic shock, the first transthoracic echocardiography will be performed within twenty four hours of ICU admission. A second echocardiogram will be conducted seventy two hours after the first, and a third examination will be carried out at the time of clinical recovery, which is defined as the point when all vasopressors and inotropic support have been discontinued.

In the control group of patients with sepsis but without shock, the first transthoracic echocardiography will also be performed within twenty four hours of diagnosis. The second echocardiography will be done seventy two hours later, and the third will be carried out either on the seventh day or at the time of antibiotic deescalation, whichever occurs later.

All echocardiographic examinations will be performed by a single trained and certified cardiologist with expertise in echocardiography. The procedure will be done with the patient in the supine or left lateral position using a three point five megahertz ultrasound transducer. All image data will be recorded and stored in digital cine loop format for further analysis.

 
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