| CTRI Number |
CTRI/2022/03/040761 [Registered on: 03/03/2022] Trial Registered Prospectively |
| Last Modified On: |
25/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Measurement of blood flow time in carotid artery by ultrasound and to assess its predictability in assessing intravenous fluid response in patients admitted with hypotension |
|
Scientific Title of Study
|
Ultrasonic Measurement of Corrected Carotid Flow Time as a Predictor of Fluid Responsiveness in Undifferentiated Shock: A Prospective Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Davis Cherian |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Critical Care Unit,
Department of Anaesthesiology, Room Number 026604, Level 6, AIIMS, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9843690069 |
| Fax |
|
| Email |
cherian.davis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gaurav Jain |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Critical Care Unit,
Department of Anaesthesiology, Room Number 026604, Level 6, AIIMS, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8808631209 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gaurav Jain |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Critical Care Unit,
Department of Anaesthesiology, Room Number 026604, Level 6, AIIMS, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8808631209 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
|
Source of Monetary or Material Support
|
| Critical Care Unit, Department of Anaesthesiology, AIIMS, Rishikesh |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| None |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Davis Cherian |
AIIMS, Rishikesh |
Critical Care Unit,
Department of Anaesthesiology, Room Number 026604, Level 6, AIIMS, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL |
9843690069
cherian.davis@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I958||Other hypotension, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
New onset Septic/Hypovolemic shock |
|
| ExclusionCriteria |
| Details |
BMI >30 kg/m2.
Cardiac arrhythmia
Valvular heart disease
Cardiomyopathy
Carotid artery stenosis
COPD
Symmetric anterior bilateral B lines on Lung Ultrasonography
Poor transthoracic window
Cardiogenic/obstructive shock
Patients on vasopressor therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Corrected carotid flow time as a predictor of fluid responsiveness in patients presenting with septic/hypovolemic shock |
Baseline
Post first fluid bolus |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between corrected Carotid flow time, Lung USG values and Stroke volume during initial fluid resuscitation of patients presenting with septic/hypovolemic shock |
Baseline and after each fluid bolus |
| Comparison of baseline variables among the responders versus non-responders to fluid resuscitation |
Baseline |
| Incidence of repeat hypotension, need of vasopressors and total fluid administered among responders versus non-responders to fluid resuscitation, in patients presenting with septic or hypovolemic shock |
First 24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/03/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fluids are being administered for resuscitation to increase intravascular volume thereby increasing cardiac output and blood pressure in patients admitted with hypovolemic/septic shock. Multiple methods have been recommended to assess fluid responsiveness. Measurement of changes in Corrected Carotid flow time (cCFT) is one of the non-invasive techniques to assess the changes in fluid status using bedside ultrasonography. In this study, we aim to evaluate the role of Corrected Carotid Flow Time measured by ultrasonography in predicting fluid responsiveness in patients presenting with undifferentiated shock. |