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CTRI Number  CTRI/2023/04/052063 [Registered on: 27/04/2023] Trial Registered Prospectively
Last Modified On: 05/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Estimation of the degree of agreement between the findings of cardiac output by echocardiography and minimally invasive device in septic shock patients. 
Scientific Title of Study   Comparison of cardiac output by transthoracic echocardiography and minimally invasive device in septic shock patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KUNDAN KUMAR 
Designation  Senior Resident 
Affiliation  PGIMER, Dr. R.M.L. Hospital , New Delhi 
Address  Department of critical care medicine, Trauma building , Second floor,Dr RML Hospital, Baba kharak singh margh, Connaught place, New Delhi

Central
DELHI
110001
India 
Phone  7856878913  
Fax    
Email  kundanshu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prof Amlendu Yadav 
Designation  Professor 
Affiliation  PGIMER, Dr. R.M.L. Hospital , New Delhi 
Address  Department of critical care medicine, Trauma building , Second floor,Dr RML Hospital, Baba kharak singh margh, Connaught place, New Delhi

Central
DELHI
110001
India 
Phone  9711315438  
Fax    
Email  yadavamlendu@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  KUNDAN KUMAR 
Designation  Senior Resident 
Affiliation  PGIMER, Dr. R.M.L. Hospital , New Delhi 
Address  Department of critical care medicine, Trauma building , Second floor,Dr RML Hospital, Baba kharak singh margh, Connaught place, New Delhi

Central
DELHI
110001
India 
Phone  7856878913  
Fax    
Email  kundanshu@gmail.com  
 
Source of Monetary or Material Support  
PGIMER,Dr.R.M.L. Hospital, New Delhi 
 
Primary Sponsor  
Name  PGIMER Dr RML Hospital New Delhi 
Address  Department of critical care medicine, Trauma building , Second floor,Dr RML Hospital, Baba kharak singh margh, Connaught place, New Delhi 
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 Kundan kumar  PGIMER, Dr. R. M. L. Hospital, New delhi  Department of critical care medicine, Trauma building ,room no 202, Second floor,Dr RML Hospital, Baba kharak singh margh, Connaught place, New Delhi
Central
DELHI 
7856878913

kundanshu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. RML Hospital, New Delhi, Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I958||Other hypotension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients aged more than equal to 18 years
2. Patients with diagnosis of Septic shock
3. Patients with ICU stay of at least 24 hours
4. Patients on mechanical ventilatory support
 
 
ExclusionCriteria 
Details  1. Refusal of Consent
2. Drop out during sampling period
3. Patients having aortic stenosis and atrial
fibrillation
4. Patients having Confirmative or supportive
diagnosis of other causes of shock
•Any contraindication to arterial line placement
•Pregnancy
•Age >70
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To examine the degree of agreement of the cardiac output findings of transthoracic echocardiography and minimally invasive device in septic shock patients.   12 months 
 
Secondary Outcome  
Outcome  TimePoints 
To identify if gender, age and body surface can affect the bias between the two devices  12 months 
 
Target Sample Size   Total Sample Size="149"
Sample Size from India="149" 
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)   01/05/2023 
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)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

For assessment of hemodynamic status and cardiac function, cardiac output is usually used as a surrogate parameter. Many minimally invasive and non invasive devices are used for cardiac output measurement in ICU. For minimally invasive cardiac output measurement the arterial pressure cardiac output measuring device(FloTrac) will be used in this study. It is minimally invasive and continuous cardiac output measuring device and works on arterial pressure waveform analysis. Transthoracic echocardiography is a non invasive method of measurement of cardiac output which is going to be used in this study. By this method left ventricular outflow tract diameter ( in parasternal long axis view) and velocity time integral ( in apical 5 chamber view) is derived and used for cardiac output measurement 

All consecutive patients with clinical diagnosis / suspicion of septic shock at ICU admission will be enrolled. Echocardiography and 12 lead ECG will be performed to rule out aortic stenosis and atrial fibrillation. Written informed consent from first degree relatives will be taken. After connecting the patient to minimally invasive device monitor, Transthoracic Echocardiography will beperformed by investigator within the first 6 hours of ICU admission and again after every 24 hours unless the monitor get disconnected or patient develops atrial fibrillation. The study will continue for maximum of 48 hrs after first transthoracic echocardiographic examination. The cardiac output data from the minimally invasive device will be taken at the time of echocardiographic cardiac output measurement. Analysis of transthoracic cardiac output data will be done by the investigator blinded to arterial pressure cardiac output data.

 
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