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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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