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CTRI Number  CTRI/2024/07/070774 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 16/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Different methods to measure functional capacity of heart. 
Scientific Title of Study   A prospective observational study to compare relationship between minimally invasive and non-invasive cardiac output measurement in septic patients with or without vasopressor therapy admitted to 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  Dr Lalit 
Designation  Post graduate student, department of anaesthesia 
Affiliation  Lady hardinge medical college and associated hospitals 
Address  Department of Anaesthesia, Lady hardinge medical college, Shaheed bhagat singh marg, New Delhi , India

Central
DELHI
110001
India 
Phone  9871946491  
Fax    
Email  Lalitksw007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Maitree Pandey 
Designation  Director Professor & Head of Department 
Affiliation  Lady hardinge medical college and associated hospitals 
Address  Department of Anaesthesia, Lady hardinge medical college, Shaheed bhagat singh marg, New Delhi , India

Central
DELHI
110001
India 
Phone  9810570515  
Fax    
Email  maitreepandey@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nishant Kumar 
Designation  Professor 
Affiliation  Lady hardinge medical college and associated hospitals 
Address  Department of Anaesthesia, Lady hardinge medical college, Shaheed bhagat singh marg, New Delhi , India

Central
DELHI
110001
India 
Phone  9811934659  
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Source of Monetary or Material Support  
Lady hardinge medical college and associated hospitals, new Delhi - 110001 
 
Primary Sponsor  
Name  Lady hardinge medical college 
Address  Shaheed bhagat Singh marg,Lady hardinge medical college, DIZ area, connaught place,new Delhi, Delhi-110001 
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 Lalit  Lady hardinge medical college and associated hospitals  Department of Anaesthesia, Lady hardinge medical college, Shaheed bhagat singh marg, new delhi ,India
Central
DELHI 
9871946491

Lalitksw007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee of human research, LHMC and associated hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. more than 18 years old
2. either sex
3. septic patients with or without vasopressor therapy admitted to intensive care unit and arterial line in situ. 
 
ExclusionCriteria 
Details  1. patients with valvular dysfunction, rhythm other than normal sinus rhythm.
2. patients with poor window on cardiac ultrasound. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Z test statistic of correlation coefficient (Spearman coefficient) between minimally invasive and non-invasive cardiac output in septic patients with or without vasopressor therapy admitted to intensive care unit.  Measurements shall be made only once in one patient during the stay in ICU for the purpose of study. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Bias will be calculated by means of difference between CO obtained by minimally invasive and non-invasive methods in septic patients with or without vasopressor therapy admitted to intensive care unit

2.Precision will be calculated by standard deviation of the differences between CO calculated by minimally invasive and non-invasive methods.

3.Agreement by Bland -Altman analysis
 
calculations will be done after the readings obtained at the time of diagnostic scan. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   28/07/2024 
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="1"
Months="1"
Days="21" 
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 intensive care facilities, one of the most frequently encountered situation is sepsis. It is a life-threatening organ dysfunction caused by an unregulated response of a host which may lead to septic shock, which is a state of widespread reduction in effective tissue perfusion.1,2 This shock may be due to vasodilation or sepsis induced cardiomyopathy which depresses myocardial intrinsic contractility. Cardiac output and oxygen delivery may be impaired in sepsis due to primary myocardial dysfunction and decreased systemic vascular resistance (SVR) requiring the use of vasopressors.3

Cardiac output (CO) is the surrogate measure for myocardial contractility and decreased SVR and is often used to guide treatment and fluid therapy. Pulmonary artery cauterization (PAC) is the gold standard but is associated with complications like pneumothorax, arrythmias, infections, pulmonary artery injury, valve injury, knotting and thrombosis leading to embolism and it is not routinely recommended.4

Cardiac ultrasound is an important tool for the assessment of cardiac structures, filling status and the contractility of the heart in critically ill patients. It is  a reliable tool and considered as precise as the reference method PAC. Calculation of left ventricular volumes from apical four and two chamber views is the accepted method to calculate stroke volume which is the difference between end diastolic and end systolic left ventricular volume. But cardiac ultrasound is performer dependant and cannot give a real time measurement.5,6

Minimally invasive pulse contour analysis is a relatively newer tool which is based on the principle that area under the systolic part of the arterial pressure waveform corresponds to the stroke volume, which in turn maybe influenced by SVR. It is termed as arterial pressure based cardiac output (APCO) and requires an arterial line. It can also measure stroke volume variation and pulse pressure variation which are important in predicting fluid responsiveness of the patient. More-over it is not performer dependant and doesn’t need any external calibration. It gives beat to beat variability and real time cardiac output (CO) measurements.7,8

There are lot of studies comparing the invasive and non-invasive methods, however due to difference in measurement methods, the minimally invasive CO may not be reflective of the measurement by ultrasound in certain conditions. There are only limited comparative studies between minimally invasive and non-invasive methods in septic patients with or without vasopressor therapy admitted to  intensive care unit. Therefore, we have planned to study the relationship between the minimally invasive method with the non-invasive method of cardiac output measurement. 
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