| CTRI Number |
CTRI/2025/06/088741 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Evaluation and Compararison of diagnostic and prognostic accuracy of different biomarkers like Procalcitonin, CD64, Group II phospholipase A 2 and Human neutrophil lipocalin for adult sepsis and septic shock in sick patients admitted in Emergency Department. |
|
Scientific Title of Study
|
Comparative evaluation of diagnostic and prognostic accuracy of Procalcitonin, CD64, Group II phospholipase A 2 and Human neutrophil lipocalin for adult sepsis and septic shock patients admitted in Emergency Department. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG 2025/1 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanmoy Ghatak |
| Designation |
Associate Professor |
| Affiliation |
SGPGI |
| Address |
Department of Emergency Medicine . sanjay gandhi post graduate Institute of medical sciences. Raibareilly road. Lucknow 226014.
Lucknow
UTTAR PRADESH
226014.
India |
| Phone |
09455037848 |
| Fax |
|
| Email |
tanmoyghatak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanmoy Ghatak |
| Designation |
Associate Professor |
| Affiliation |
SGPGI |
| Address |
Department of Emergency Medicine . sanjay gandhi post graduate Institute of medical sciences. Raibareilly road. Lucknow 226014.
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
09455037848 |
| Fax |
|
| Email |
tanmoyghatak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanmoy Ghatak |
| Designation |
Associate Professor |
| Affiliation |
SGPGI |
| Address |
Department of Emergency Medicine . sanjay gandhi post graduate Institute of medical sciences. Raibareilly road. Lucknow 226014.
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
09455037848 |
| Fax |
|
| Email |
tanmoyghatak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute of Medical science Raibarielly Road Lucknow 226014. Institute will grant Intramural project upto 5 lakhs. |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Post Graduate Institute |
| Address |
Raibareilly Road Lucknow 226014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Tanmoy Ghatak |
Department of Emergency Medicine |
Sanjay Gandhi Post Graduate Institute of Medical Sciences Raibareilly Road Lucknow 226014
Lucknow
UTTAR PRADESH |
09455037848
tanmoyghatak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGPGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
healthy volunteer |
patient relatives |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Age more than 18 years
2. sepsis according to sepsis 3 criteria.
3, emergency department |
|
| ExclusionCriteria |
| Details |
1. Not giving consent for test.
2. Patients with immune-related diseases- can influence biomarker level.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The diagnostic accuracy of CD64, PLA 2GIIA, HML and Procalcitonin in sepsis and septic shock patients in emergency department.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any correlation between mortality with admission biomarker levels & admission SOFA score. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/06/2025 |
| 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
|
Project summary-
Though
it’s well known that timely identification of septic shock is decisive to
improve any septic patient’s mortality, no biomarker is still existing to
detect it in the initiation. Procalcitonin, CD64, Group II phospholipase
A 2, and Human neutrophil lipocalin are the promising one among 260 tested biomarkers.
In our study, we want to compare the diagnostic accuracy of these biomarkers in
septic shock patients in our emergency department. Additionally, prognostic
guidance if any will be seen. |