| CTRI Number |
CTRI/2026/03/105167 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see how useful pancreatic stone proteins are as biomarker to detect sepsis early and compare it with ESR and CRP biomarkers |
|
Scientific Title of Study
|
Efficacy of pancreatic stone proteins in early diagnosis of sepsis and comparison of its temporal trends with ESR and CRP - A longitudinal 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 |
Paras Singh |
| Designation |
Paediatric Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College and KLEs Dr Prabhakar Kore Hospital and Medical Research Center, Nehru Nagar, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
8279462359 |
| Fax |
|
| Email |
paras.singh929315@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Tanmaya Metgud |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College and KLEs Dr Prabhakar Kore Hospital and Medical Research Center, Nehru Nagar, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9845395294 |
| Fax |
|
| Email |
tanmayametgud@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Paras Singh |
| Designation |
Paediatric Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College and KLEs Dr Prabhakar Kore Hospital and Medical Research Center, Nehru Nagar, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
8279462359 |
| Fax |
|
| Email |
paras.singh929315@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum, Karnataka, India - 590010 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College and KLEs Dr Prabhakar Kore Hospital and Medical Research Center, 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 |
| Paras Singh |
Dr Prabhakar Kore Hospital and Medical Research Center |
Paediatric Emergency, 3rd Floor, Department of Paediatrics Belgaum KARNATAKA |
8279462359
paras.singh929315@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: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 month to 18 years admitted to specified units presenting with sepsis symptoms per the International Paediatric Sepsis Consensus Conference (IPSCC) guidelines - 2024, which recommends that sepsis can be identified in children with a phoenix sepsis score of more than 2 or, sepsis confirmed by a positive blood culture isolate. |
|
| ExclusionCriteria |
| Details |
1. Patients with functional disorders unrelated to sepsis (autoimmune disorders, malignancies, non-infectious SIRS causes)
2. Patients with surgery in past 6 months.
3. Patients with underlying renal, cardiac or hepatic failure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic efficacy of Pancreatic Stone Proteins for early sepsis detection |
Day 1, Day 3, Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pancreatic Stone Proteins trend vs ESR and CRP |
Day 1, Day 3, Day 5 |
| Correlation of PSP with positive blood cultures. |
|
| Association of PSP with outcomes (organ failure, mortality) |
|
|
|
Target Sample Size
|
Total Sample Size="53" Sample Size from India="53"
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)
|
20/03/2026 |
| 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="10" 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
|
WHO defines sepsis a life-threatening condition that arises when the body’s response to infection causes injury to its own tissues and organs. Sepsis remains a significant cause of morbidity and mortality in the paediatric population. Early detection is crucial for effective management, prompting ongoing research into reliable biomarkers. Traditionally, biomarkers such as Erythrocyte Sedimentation Rate (ESR) and C- Reactive Protein (CRP) have been utilised, but their specificity and sensitivity limitations have led to the exploration of novel indicators like Pancreatic Stone Proteins (PSP). Pancreatic stone protein (PSP), a C-type lectin protein, is a well-defined biomarker of sepsis. PSP activates polymorphonuclear neutrophils (PMNs) and aggravates multiple organ dysfunction syndrome. PSP levels are correlated with disease severity, vasopressor support, progression to organ failure, mechanical ventilation, renal replacement therapy, length of stay, and mortality. As PSP is a C-type lectin protein, it may have a role in activating innate immunity through the C-type lectin receptors (CLRs) of the study. Through this study, we aim to evaluate the diagnostic value of PSP in Indian paediatric age group, its evolving levels throughout the course of the disease and how it compares to other pre-existing markers. Existing biomarkers have proven to have a variable sensitivity in early course of sepsis, with their elevation observed in non-septic SIRS as well. There is a wide knowledge gap in early detection of sepsis, with the only diagnostic modality being a positive blood culture. As a confimatory blood culture requires a standard incubation time of 5 days, to develop a diagnostic test for confirmation of sepsis onset early on becomes pivotal in improving the existing prognostic outcomes. |