| CTRI Number |
CTRI/2025/06/089667 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To identify whether a patient with decreased blood pressure will respond to giving fluids |
|
Scientific Title of Study
|
A Study to Compare Carotid Doppler and Hemodynamic Parameters as Marker of Fluid Responsiveness in Undifferentiated Shock |
| 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 Sumit Ray |
| Designation |
Senior Consultant & Head of the Department |
| Affiliation |
Holy Family Hospital |
| Address |
Department of Critical Care Medicine Holy Family Hospital, Okhla Road South DELHI 110025 India |
| Phone |
09810614433 |
| Fax |
|
| Email |
drsray67@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sumit Ray |
| Designation |
Senior Consultant & Head of the Department |
| Affiliation |
Holy Family Hospital |
| Address |
Department of Critical Care Medicine Holy Family Hospital, Okhla Road
DELHI 110025 India |
| Phone |
09810614433 |
| Fax |
|
| Email |
drsray67@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Sumit Ray |
| Designation |
Senior Consultant & Head of the Department |
| Affiliation |
Holy Family Hospital |
| Address |
Department of Critical Care Medicine Holy Family Hospital, Okhla Road
DELHI 110025 India |
| Phone |
09810614433 |
| Fax |
|
| Email |
drsray67@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Holy Family Hospital
Okhla Road
New Delhi-110025
India |
|
|
Primary Sponsor
|
| Name |
Dr Sumit Ray |
| Address |
Department of Critical Care Medicine
Holy Family Hospital Okhla Road New Delhi-110025
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Sumit Ray |
Holy Family Hospital |
Department of Critical Care Medicine
Holy Family Hospital
Okhla Road
New Delhi-110025
India South DELHI |
09810614433
drsray67@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Holy Family Hospital Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I959||Hypotension, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Changes in Corrected Flow Time |
Corrected carotid flow time will be measured within 2 minutes of fluid challenge by the same observer and with the same methodology. |
| Comparator Agent |
Changes in Mean Arterial Pressure |
Mean Arterial Pressure will be noted immediately after bolus immediately and two minutes post fluid challenge. |
| Comparator Agent |
Changes in Pulse Pressure |
Pulse Pressure will be noted immediately after bolus immediately and two minutes post fluid challenge. |
| Comparator Agent |
Corrected Carotid Flow Time |
The patient will be placed in a 30-45° semi recumbent position. The long axis view of the right carotid artery will be obtained, and the carotid diameter will be measured 1 cm proximal to the carotid bulb from intima to intima. Doppler tracings were obtained by placing the 0.5 mm sample gate at the center and parallel to the vessel. Doppler examination was performed while the Doppler beams were adjusted to ensure less than 60° of angle for the best signal. Then, cardiac cycle time and carotid flow time is measured.  |
| Intervention |
Fluid Responsiveness- By Mini Fluid Challenge |
A mini fluid challenge of 4ml/kg will be infused over five minutes. Fluid bolus will be stopped in case of rapidly rising oxygen requirement. Response is measured by increase in LVOT VTI by 10% and are divided into two groups. 1.Fluid responders more than or equal to 10% increase in LVOT VTI and 2.Fluid Non responders less than or equal to 10% increase in LVOT VTI. Total duration of the intervention is 5 minutes. |
| Comparator Agent |
LVOT VTI |
LVOT VTI will be measured at the previously marked sight by the same observer and previously mentioned methodology within 2 minutes of fluid challenge |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than or equal to 18 years of age
2.Undifferentiated shock with clinical signs of
shock as defined as any of the following
a. Mean arterial pressure less than 65 mmHg
b. Requiring vasopressor support to maintain
mean arterial pressure more than 65mmHg
c. Lactate more than 2mmol per litre.
d. Oliguria defined as urine output less than
0.5ml per kg per hour
e. Capillary refill time more than 5 seconds |
|
| ExclusionCriteria |
| Details |
1.Moderate to severe valvular heart disease
2.Obstructive shock
3.Carotid artery stenosis
4.Poor transthoracic window
5.Isolated Cardiogenic shock
6.Not willing for consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analyze the predictive power of corrected carotid flow time to differentiate between fluid responders and non-responders in patients with undifferentiated shock. |
Baseline 0 & at 2min after bolus |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare variables like systolic blood pressure, diastolic blood
pressure, pulse pressure, mean arterial pressure as predictors of fluid resuscitation with
undifferentiated shock. |
At baseline 0 & at 2 min after bolus |
|
|
Target Sample Size
|
Total Sample Size="22" Sample Size from India="22"
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)
|
15/07/2025 |
| 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="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a prospective, observational, cohort study which will be conducted in the critical care department at holy family hospital, New Delhi. Patient who are above the age of 18 years old, in shock, which is defined as: or mean arterial pressure <65 mmHg, decreased urine output (< 0.5ml/kg/hour), or serum lactic acid >2 mEq/L after fulfilling the eligibility criteria and the written consent process will be enrolled in the study. Baseline vital variables heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse pressure will be noted by the invasive arterial waveform trace on the MX430 Philips Intellivue patient monitor by one observer. A second observer will do a carotid ultrasound using the linear array transducer with a frequency of 13–6 MHz of the Philips CX50 echocardiography machine.Corrected carotid artery flow time is measured. A third observer trained in critical care ultrasound will measure Left ventricular outflow tract velocity time integral (LVOT VTI) in an apical 5 chambers cavity window with a low frequency phased array probe(1-5MHz). Three observers will be blinded to each other’s findings to decrease the bias. A Fluid challenge of 4ml/kg will be infused over five minutes. Post fluid challenge all hemodynamic parameters (HR, SBP, DBP, MAP, PP) will be noted immediately after bolus immediately and two minutes post fluid challenge. Corrected carotid flow time will be measured within 2 minutes of fluid challenge by the same observer and with the same methodology. LVOT VTI will be measured at the previously marked sight by the same observer and previously mentioned methodology within 2 minutes of fluid challenge. Average of the three readings will be calculated. Through the course of study, the three observers will be blinded to each other findings. To reduce inter observer variability same observer will do the repeat ultrasounds also. The maintenance fluid and further treatment will be decided as per the discretion of the treating physician. This study aims to analyze and compare the changes in corrected carotid flow time, pulse pressure, and mean arterial pressure in response to fluid challenge in patients experiencing undifferentiated shock. By examining these hemo dynamic parameters, we hope to enhance our understanding of fluid resuscitation’s effectiveness in this critical patient population.
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