| CTRI Number |
CTRI/2025/12/099678 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Early Identification of Shock Using Bedside Ultrasound and Blood Markers in Critically Ill Patients |
|
Scientific Title of Study
|
Utility of Point of Care Ultrasound (POCUS) in Early Diagnosis of Shock and Its Correlation with Multiple Biomarkers |
| 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 Jag Mohan Kumar |
| Designation |
Senior Resident (DM std) |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India
Ranchi
JHARKHAND
834009
India |
| Phone |
9430373508 |
| Fax |
|
| Email |
jagmgm2k3@gmail..com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jay Prakash |
| Designation |
Associate Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India
Ranchi
JHARKHAND
834009
India |
| Phone |
08084715507 |
| Fax |
|
| Email |
dr.jay_prakash@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jay Prakash |
| Designation |
Associate Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India
Ranchi
JHARKHAND
834009
India |
| Phone |
08084715507 |
| Fax |
|
| Email |
dr.jay_prakash@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India
PIN-834009 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [Nil] |
|
|
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 Jay Prakash |
Rajendra Institute of Medical Sciences |
Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India
Ranchi
JHARKHAND |
08084715507
dr.jay_prakash@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee, RIMS, RANCHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years.
Patients with clinical features of circulatory shock (criteria of shock consisted of hypotension (systolic blood pressure less than 90 mm Hg) or a 30-mmHg fall in baseline blood pressure) with one or more signs of organ hypoperfusion- cool extremities, confusion or altered mental status, heart rate more than 100, respiratory rate more than 22. urine output less than 0.5 mL/kg/h for the previous 6 h, or blood lactate more than 2 mmol/l). Further laboratory findings that supported the diagnosis of shock include lactate more than 2 mmol/L, base deficit less than 4 mEq/L, and Paco2 less than 32 mm Hg.
Shock index more than 1. Shock index (SI) is defined as the heart rate (HR) divided by systolic blood pressure (SBP).
|
|
| ExclusionCriteria |
| Details |
Pregnant patients.
Patients with circulatory shock secondary to trauma.
Patients already have ascites and pleural effusion because of known chronic diseases.
Patients/attendants not giving consent for the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of the RUSH protocol in the early diagnosis of various types of shock. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A. To determine the diagnostic performance of lactate, NT-proBNP, & INR in identifying various types of shock using ROC curve analysis.
B. To identify optimal cutoff values for each biomarker in predicting various types of shock using Youden’s index & ROC analysis.
C. Comparing the diagnostic ability of the RUSH protocol, INR, lactate, & NT-proBNP for various types of shock.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
03/02/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 is a life threatening condition commonly encountered in critically ill patients and requires rapid identification of its underlying cause for timely management. Early differentiation between various types of shock is often difficult at the bedside using clinical examination alone. Point of care ultrasound using the RUSH protocol and biochemical markers such as lactate NT proBNP and INR may help in early diagnosis and classification of shock. This prospective observational study was conducted in the Department of Critical Care Medicine at RIMS Ranchi. Adult patients who developed shock during ICU stay were enrolled. Shock was defined as systolic blood pressure less than 90 mmHg with a shock index greater than 1. As soon as shock was identified a bedside ultrasound examination was performed using the RUSH protocol and blood samples were simultaneously collected for estimation of lactate NT proBNP and INR. The RUSH protocol findings and biomarker values obtained at the time of initial shock recognition were used to identify the type of shock. The final diagnosis of shock was established later based on detailed clinical evaluation laboratory investigations imaging studies and response to treatment. Diagnostic performance of lactate NT proBNP INR and RUSH protocol was assessed using ROC curve analysis and optimal cutoff values for biomarkers were determined using Youdens index. The study aims to evaluate and compare the diagnostic utility of bedside ultrasound and commonly available biomarkers in early identification and differentiation of various types of shock. The findings of this study may help clinicians in rapid decision making and improve early management of shock in critical care settings. |