| 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
|
|
|
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
|
|
|
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.
|