| CTRI Number |
CTRI/2024/06/069149 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A prospective observational study to assess the Prevalence and Outcome of Sepsis-induced Cardiomyopathy in Intensive Care Units |
|
Scientific Title of Study
|
To study the Prevalence and Outcomes of Sepsis-induced Cardiomyopathy (SICM) in an Intensive Care Unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zainab Khatoon |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9007997220 |
| Fax |
|
| Email |
zainabkhatoon.123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abu Nadeem |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837757772 |
| Fax |
|
| Email |
drabunadeem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abu Nadeem |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837757772 |
| Fax |
|
| Email |
drabunadeem@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh- 202001, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
JNMCH Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical College AMU |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, AMU |
| 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 Zainab Khatoon |
Jawaharlal Nehru Medical College |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University
Aligarh
UTTAR PRADESH |
9007997220
zainabkhatoon.123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Regd.)Jawaharlal Nehru Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sepsis or septic shock admitted in the ICU |
|
| ExclusionCriteria |
| Details |
Patients whose diagnostic criteria does not fulfill sepsis or septic shock, patients shifted to ICU after elective surgeries, pregnant patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the prevalence and outcome of Sepsis induced cardiomyopathy in the ICU |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the need of inotropic support, mechanical ventilation and/ or tracheostomy |
During ICU stay |
|
|
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)
|
30/06/2024 |
| 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="2"
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
|
In this non-randomised observational study, all patients with diagnosis of suspected sepsis admitted to the ICU will be selected. Sepsis will be defined according to the Third International Consensus Definitions for Sepsis and Septic shock; SOFA score will be used to identify organ dysfunction. Along with baseline parameters, transthoracic echocardiography will be done to assess the presence of cardiomyopathy in all such patients. Thereafter, patients will be divided into 2 groups: Group 1 comprising all those without cardiomyopathy and Group 2 comprising all those with cardiomyopathy. Baseline characteristics, per-existing comorbidities, need for inotropic support, mechanical ventilation and/or tracheostomy will be compared along with duration of ICU stay and mortality . |