| CTRI Number |
CTRI/2025/12/099340 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ROLE OF PRESEPSIN IN SEPSIS PATIENTS |
|
Scientific Title of Study
|
PRESEPSIN: A PROGNOSTIC TOOL FOR SEPSIS: A PROSPECTIVE 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 |
KANISHKA DAS |
| Designation |
POST GRADUATE |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of General Surgery, KLE Jawaharlal Nehru Medical college, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
6266350322 |
| Fax |
|
| Email |
kanishkadas030@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V M Pattanshetti |
| Designation |
PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of General Surgery, KLE Jawaharlal Nehru Medical college, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9886175471 |
| Fax |
|
| Email |
viceprincipaldrvmp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V M Pattanshetti |
| Designation |
PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of General Surgery, KLE Jawaharlal Nehru Medical college, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9886175471 |
| Fax |
|
| Email |
viceprincipaldrvmp@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore hospital and medical research centre, Belagavi, Karnataka, India, 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Kanishka Das |
| Address |
S2, Sri Sai Apartment, Shivabasava nagar, Belagavi |
| Type of Sponsor |
Other [Self] |
|
|
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 Kanishka Das |
KLE Dr Prabhakar Kore hospital and medical research centre |
Intensive care unit, Nehru nagar, Belagavi
Belgaum
KARNATAKA |
6266350322
kanishkadas030@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: R651||Systemic inflammatory response syndrome (SIRS) of non-infectious origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Serum presepsin level |
Blood is drawn through iv cannula on the 1st day of icu admission and tested through ELISA technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS ABOVE 18 YEARS OF AGE |
|
| ExclusionCriteria |
| Details |
PATIENTS ABOVE 18 YEARS OF AGE, PATIENT NOT ALREADY DIAGNOSED WITH SEPSIS, SEPTIC SHOCK, SIRS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the role of presepsin in prognosis of sepsis for better treatment plan |
On day 1 of ICU admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess presepsin as novel biomarker for sepsis |
after the values of presepsin |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
23/12/2025 |
| 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="1"
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
|
On day 1 of ICU admission, patient’s blood sample will be drawn along with other routine investigations and sent to lab where serum will be separated and the level of presepsin will be checked using ELISA technique. |