| 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
|
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College, 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 |
| 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
|
|
|
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. |