| 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
|
|
|
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
|
|
|
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. |