| CTRI Number |
CTRI/2025/09/093997 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Validation Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Prokineticin-2 as a Diagnostic Marker of Sepsis: A Comparative Study with Procalcitonin and Blood Culture |
|
Scientific Title of Study
|
Diagnostic validity of Prokineticin-2 compared to Procalcitonin and Blood culture in patients with sepsis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ojas Kumar Aggarwal |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College Belagavi
Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8527809859 |
| Fax |
|
| Email |
ojask043@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Smita S. Sonoli |
| Designation |
Professor and Head |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College, Belagavi
Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9901662601 |
| Fax |
|
| Email |
naragundsmita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ojas Kumar Aggarwal |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College, Belagavi
Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8527809859 |
| Fax |
|
| Email |
ojask043@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Belagavi, Karnataka, India- 110063 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Nehru Nagar Belagavi |
| Type of Sponsor |
Private 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 Ojas Kumar Aggarwal |
HI Tech laboratory |
Dr. Prabhakar kore hospital, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA |
8527809859
ojask043@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R798||Other specified abnormal findingsof blood chemistry, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with suspected of sepsis in IPD patients
2 Before antibiotic initiation, sample sent for Aerobic Bacterial Blood culture and Procalcitonin for the same patient
3 Estimation of Prokineticin-2 within 1 hour to prevent variability
4 Age 18 years or more
|
|
| ExclusionCriteria |
| Details |
1.Prior antibiotic therapy more than 24 hours before sample collection
2. Either of Blood culture or Procalcitonin investigation not advised
3. Negative Blood culture reported are excluded
4. Procalcitonin level less than or equal to cut off value 0.5ng/ml are excluded
5. Patients with autoimmune diseases, HIV, HBsAg, HCV are excluded.
6. Patients on long term steroids immunosuppressants chemotherapy or with terminal illness malignant cancer end-stage liver or renal disease are excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prokineticin-2 can be useful marker to diagnose sepsis effectively |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/09/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Procalcitonin is used to diagnose sepsis in critically ill patients. But Procalcitonin is not specific to sepsis because it can be raised in cases of burns, trauma etc. Procalcitonin sensitivity and specificity are 64.7 percent and 50 percent on day 1 and 95.5 percent and 95.1 percent on 28-day mortality respectively. These factors lead to validate new sepsis marker that is, Prokineticin 2. Prokineticin-2 (PK-2) is considered a next generation inflammatory marker with superior diagnostic value. Prokineticin-2 sensitivity and specificity are 70.6 percent and 50 percent on day 1 and 98.4 percent and 95.5 percent on 28-day mortality respectively. As compared to traditional biomarkers, Prokineticin 2 can be more appropriate method to diagnose sepsis in patients
Procalcitonin PCT is used to diagnose sepsis in critically ill patients. Procalcitonin (PCT), a biomarker elevated in bacterial infections, has been extensively studied for its potential role in sepsis diagnosis. The diagnostic accuracy of Procalcitonin in identifying sepsis among adult patients admitted to emergency departments. the authors aimed to clarify the utility of PCT as a reliable diagnostic tool, addressing inconsistencies in previous research and providing updated evidence to guide clinical decision-making
NEED FOR STUDY
A study published in year 2025 by Bhat et.al pointed out that Procalcitonin was assessed through point of care testing in ICU whereas PK-2 was measured using ELISA test in laboratory therefore stating possibility that using two different methods for two biomarkers may have introduced variability and potential errors in results.
Therefore, keeping these points in view, we would like to assay Procalcitonin and Prokineticin-2 using ELISA and also want to compare diagnostic validity of Prokineticin-2 with procalcitonin and blood culture for diagnosing sepsis on early basis |