| CTRI Number |
CTRI/2025/08/092165 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find the relation between Corrected Carotid Flow Time and Left Ventricular Outflow Tract- Velocity Time Integral using Echocardiography in ICU Patients |
|
Scientific Title of Study
|
Correlation between Corrected Carotid Flow
Time and Left Ventricular Outflow Tract Velocity-Time Integral
using Trans-Thoracic Echocardiography for assessing Fluid
Responsiveness in septic shock patients admitted to ICU : A
Prospective observational 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 |
Mainak Baidya |
| Designation |
Senior Resident...Post Doctoral Fellow |
| Affiliation |
AIIMS PATNA |
| Address |
Ramnagar Road-1 (2nd Crossing), Agartala Tripura(West)
West Tripura
TRIPURA
799102
India |
| Phone |
07907421989 |
| Fax |
|
| Email |
mainak.baidya15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Umesh Kumar Bhadani |
| Designation |
Professor and Head |
| Affiliation |
AIIMS PATNA |
| Address |
Room no 514- 5th Floor OT Complex, IPD Building, Department of Anaesthesiology,AIIMS PATNA
Patna
BIHAR
801507
India |
| Phone |
8969169123 |
| Fax |
|
| Email |
umeshbhadani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Umesh Kumar Bhadani |
| Designation |
Professor and Head |
| Affiliation |
AIIMS PATNA |
| Address |
Room no 514- 5th Floor OT Complex, IPD Building, Department of Anaesthesiology,AIIMS PATNA
Patna
BIHAR
801507
India |
| Phone |
8969169123 |
| Fax |
|
| Email |
umeshbhadani@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS PATNA |
| Address |
Phulwarisharif, Patna, Bihar-801507, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mainak Baidya |
AIIMS PATNA |
B6B Anaesthesia ICU ,6th Floor OT Complex, IPD Building, AIIMS PATNA,Phulwari Shariff, Patna, 801507
Patna
BIHAR |
07907421989
mainak.baidya15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I69||Sequelae of cerebrovascular disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients in Septic Shock as per recent surviving sepsis guidelines (SSG 2021)
|
|
| ExclusionCriteria |
| Details |
Age less than 18 and more than 85.
Poor quality of ultrasonographic imaging.
Inability to achieve a zero degree angulation of the pulsed Doppler signal for assessing LVOT or carotid flow, LVOT dynamic obstruction, cardiac arrhythmia.
Significant aortic valve disease (stenosis and/or moderate to severe insufficiency) significant carotid disease (stenosis greater than 50%)
Intracranial hypertension cerebral circulatory arrest, aortic dissection, ischemic heart disease, heart failure, and hypertensive crisis requiring vasoactive drugs.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
LVOT-VTI
Corrected Carotid Flow Time
Delta VTI
Stroke volume variation |
Baseline and after 20 minutes of Fluid Administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration on Mechanical Ventilator
Duration on Ionotropic Support |
Duration on Mechanical Ventilator at 0,7,14, 28 days
Duration on Ionotropic Support at 0,7,14, 28 days |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
14/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
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
|
Selecting an efficient method to assess Fluid responsiveness in ICU is crucial especially in first one hour of presentation in septic shock patients. Prompt administration of fluid during early resuscitation phase might prove to be an important factor in further prognosis of the patient. According to Recent Surviving Sepsis Guidelines, the second pillar of treatment is fluid resuscitation. Rationale Trans-Thoracic Echocardiography (TTE) is widely used in ICU for assessing fluid responsiveness. The left ventricular outflow tract velocity time integral (LVOT VTI) shows how the SV changes in response to fluid administration; therefore, the LVOT VTI is used to guide intravenous fluid management. However, Common Carotid Artery Flow Doppler is much easier, does not depend on adequate cardiac windows, and requires less skill and expertise than LVOT VTI.
Study Procedure Transthoracic Echocardiography will be done to assess LVOT VTI initially and 20 minutes after fluid administration. Corrected Carotid Flow Time (cCFT) will also be calculated similarly at these two time points. Fluid responsiveness will be defined if LVOT VTI is more than 17 cm or Delta VTI is less than 15 percent, and corresponding cCFT value will be taken for correlation with LVOT VTI |