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CTRI Number  CTRI/2025/07/089970 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 30/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Ultrasound guided assessment of patients presenting with Shock to the Emergency Department  
Scientific Title of Study   Point of Care Ultrasound-guided Diamond Forrester Phenotyping of Patients Presenting in Shock to the Emergency Department-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  Manjupriya G 
Designation  Junior resident Department of Emergency Medicine  
Affiliation  JIPMER Puducherry  
Address  Room No 5, First floor, Emergency Medicine Department, ED division, EMSD building, Dhanvantri nagar, JIPMER Pondicherry PONDICHERRY 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  8056308506  
Fax    
Email  manjupriya220898@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manu Ayyan 
Designation  Associate Professor Department of Emergency Medicine  
Affiliation  JIPMER Puducherry  
Address  No 7, Emergency Medicine division, First Floor EMSD Building, Jawaharlal Institute of Postgraduate Medical Education and Research DHANVANTRI NAGAR Pondicherry PONDICHERRY 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  9846556133  
Fax    
Email  manuayyan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manu Ayyan 
Designation  Associate Professor Department of Emergency Medicine  
Affiliation  JIPMER Puducherry  
Address  No 7, Emergency Medicine division, First Floor EMSD Building, Jawaharlal Institute of Postgraduate Medical Education and Research DHANVANTRI NAGAR Pondicherry PONDICHERRY 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  9846556133  
Fax    
Email  manuayyan@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research DHANVANTRI NAGAR PUDUCHERRY 605006 India 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Jawaharlal Institute of Postgraduate Medical Education and Research DHANVANTRI NAGAR PUDUCHERRY 605006 India 
Type of Sponsor  Government medical college 
 
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 Manjupriya   Jawaharlal Institute of Postgraduate Medical Education & Research.   Room No 5, First floor Emergency Medicine Department ED division EMSD building Dhanvantri nagar JIPMER Puducherry
Pondicherry
PONDICHERRY 
8056308506

manjupriya220898@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R579||Shock, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  One group -Adult undergoing fluid resuscitation in Emergency Department 
 
ExclusionCriteria 
Details  Patients with valvular pathologies or prosthetic valve
Patients with Persistent arrhythmias
Patients in whom atleast two serial measurements could not be performed
Patients with poor transthoracic or abdominal window
Pregnant Females 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will give a better understanding of haemodynamic phenotypes in hypoperfusive patients. It will provide insight into dynamic shifts in phenotypes during shock resuscitation. This will help us to better tailor resuscitation
interventions.
 

Total time for one sample size is 4 hours as study involves assessing hemodynamics of shock patient every 30 minutes for 4 hours after presenting to Emergency Department  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the correlation between phenotypic
shifts during resuscitation among various types of shock using Doppler starlings curve.

To assess the impact of this novel phenotyping
approach on patient outcomes, including
in-hospital mortality, ICU length of stay, & the development of acute kidney injury (AKI).



 
In hospital mortality
ICU length of stay
Development of AKI
Assessed at time of discharge 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   11/07/2025 
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="2"
Months="0"
Days="0" 
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  

Shock resuscitation is one of the most challenging modalities faced by acute care providers, especially during the early hours of resuscitation. Shock, or hypoperfusion state, is a physiological derangement that needs to be corrected appropriately in a time-sensitive manner to prevent mortality and morbidity. The cornerstone in the management of shock is based on assessing the type of shock and resuscitating with fluids, vasopressors, and inotropes.Resuscitation is based on determining whether the patient has hypovolemic, distributive, cardiogenic, or obstructive shock. In recent decades, point-of-care ultrasound (POCUS) has been used during early resuscitation to identify the type of shock and augment the resuscitation process. Despite these advancements and regularly updated international treatment guidelines, the optimal therapeutic approach is controversial, especially with regard to intravenous (IV) fluids. It has been observed that even though patients are initially fluid responsive when resuscitated with IV fluids, may later show signs of venous congestion. The coexistence of venous congestion in more than 50% of patients who were fluid responsive has been reported. A personalised resuscitation approach has been suggested based on patients’ physiological derangement.
Point of Care-guided profiling uses dichotomised Velocity time integral (VTI) and Venous Excess Ultrasound (VEXUS) to classify these phenotypes. Our current study will use one more alternative surrogate for both to add to accuracy.
















 
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