| 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
|
|
|
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
|
|
|
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. |