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CTRI Number  CTRI/2025/10/095519 [Registered on: 01/10/2025] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship between invasive and non invasive methods of determining function of the heart in critically ill patients 
Scientific Title of Study   Relationship between arterial dp/dt and left ventricular ejection fraction by modified Simpson’s method using cardiac ultrasound: An observational analytical 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  SHWETA 
Designation  post graduate student 
Affiliation  Lady Hardinge Medical College 
Address  Department of anaesthesia, 5th floor, New academic block, Lady Hardinge Medical College, New Delhi

New Delhi
DELHI
110001
India 
Phone  7428417709  
Fax    
Email  shneh1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nishant Kumar 
Designation  Director Professor 
Affiliation  Lady Hardinge Medical College, New Delhi 
Address  Department of anaesthesia, Room no. 508,new academic block, Lady Hardinge Medical College, New Delhi

New Delhi
DELHI
110001
India 
Phone  09811934659  
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Dr Nishant Kumar 
Designation  Director Professor 
Affiliation  Lady Hardinge Medical College, New Delhi 
Address  Department of anaesthesia, room no. 508, Lady Hardinge Medical College, New Delhi


DELHI
110001
India 
Phone  09811934659  
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Lady Hardinge Medical College, 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 
SHWETA  Lady hardinge medical college  Intensive care unit
New Delhi
DELHI 
7428417709

shneh1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Human Research  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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients more than 20 years of age admitted to ICU 
 
ExclusionCriteria 
Details  Patients having rhythm other than sinus.
Patients with poor cardiac window.
Patients with cardiac valvular pathology
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Spearman correlation between arterial dp/dt via HemoSphere and ejection fraction by modified Simpson’s method  day1
day2
day3 
 
Secondary Outcome  
Outcome  TimePoints 
Equation for the relationship between dp/dt and left ventricular EF by Modified Simpson’s method.  day1
day2
day3 
Derived equation will be validated by calculating bias and precision  day1
day2
day3 
Cutoff value of arterial dp/dt to predict low left ventricular ejection fraction using receiver operating characteristics (ROC) curve analysis.  day1
day2
day3 
Spearman correlation coefficient between arterial dp/dt and systemic vascular resistance and stroke volume.  day1
day2
day3 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   13/10/2025 
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="1"
Days="27" 
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  
Hemodynamic monitoring is one of the most important parameters in managing hemodynamically unstable patients, particularly in perioperative and ICU settings. The left ventricular ejection fraction is often taken as an indicator for left ventricular function and is a cornerstone for deciding management and interventions. The plan for management of the patient depends on the ventricular contractility, which will direct us to decide between inotropes, fluids or vasopressor administration. This is one of the most crucial steps towards the management of the patient who remains hypotensive or in failure, since fluid therapy may lead to worsening in case of decreased contractility of the left ventricle.
Studies show that peak left ventricular dp/dt (change in pressure over time) during iso-volumeteric contraction is a good indicator of ventricular contractility and performance that is not influenced by afterload, wall motion abnormalities, or the variation in ventricular anatomy and morphology. LV dp/dtmax is closely correlated to ejection fraction. However, catheterisation of the left ventricle for routine monitoring is neither feasible nor practical and can be done only in catheterisation laboratories.
Left ventricular ejection function (LVEF), is a commonly used method to determine ventricular contractility that can be measured non- invasively. There are, however, different methods to calculate LVEF using cardiac ultrasound. The standard accepted method is the modified Simpson’s method. This entails calculation of end-diastolic volume (EDV) and end-systolic volume (ESV) from the area of left ventricle using two views, thereby calculating LVEF. This measurement may not be accurate if the window is poor or the left ventricle is not visible. Further, it has limitations such as inter-observer variability, operator dependency and the inability to provide continuous real time data. Echocardiography doesn’t reflect the data continuously. It has to be repeated in order to assess the contractility of the heart.
Recent advancements in arterial waveform analysis have introduced arterial dp/dt – the maximal rate of pressure rise during systole; as a potential indicator of left ventricular contractility.4 Arterial dp/dt provides reasonably good tracking of LV contractility changes as loading and ionotropic conditions are varied. Arterial dp/dt measurement via pulse contour analysis from a peripheral arterial line, is minimally invasive. Strong correlation between arterial and LV dp/dtmax during manipulations of afterload and inotropic state was found, despite the influence of vascular tone. It can be monitored continuously and may be used as a surrogate for left ventricular contractility monitoring.
Studies have shown that arterial dp/dt mimics ventricular dp/dt, which is a good indicator of left ventricular contractility. Arterial dp/dt and end systolic elastance (Ees) correlate during various hemodynamic conditions, though arterial dp/dt has been found to be more accurate for assessing LV contractility with an adequate vascular volume.
There are only a few reported studies establishing a relationship between peripheral arterial waveform analysis, i.e., arterial dp/dt and LVEF. There is no universal equation available to calculate left ventricular ejection fraction from arterial dp/dt. This study is therefore being designed to find the relationship of dp/dt through arterial pulse contour and LVEF measured by modified Simpson’s method and to derive and validate a generalized equation to determine whether or not arterial dp/dt can be used as a surrogate for LVEF.
 
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