| 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
|
|
|
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
|
|
|
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. |