| CTRI Number |
CTRI/2025/07/091107 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To find diagnostic and prognostic significance of presepsin, procalcitonin and interleukin-6 in sepsis patients. |
|
Scientific Title of Study
|
Diagnostic And Prognostic significance of Presepsin, Procalcitonin and Interleukin-6 in 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 |
Dr. Arpita Suri |
| Designation |
Assistant Professor |
| Affiliation |
Maulana azad medical college |
| Address |
Room No 311, Maulana Azad Medical College, Bahadur Shah Zafar Marg
New Delhi
DELHI
110002
India |
| Phone |
63777669098 |
| Fax |
|
| Email |
arpita.lhmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Arpita Suri |
| Designation |
Assistant Professor |
| Affiliation |
Maulana azad medical college |
| Address |
Room no. 311, Maulana Azad Medical College Bahadur Shah Zafar Marg
New Delhi
DELHI
110002
India |
| Phone |
63777669098 |
| Fax |
|
| Email |
arpita.lhmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivraj Choudhary |
| Designation |
Post Graduate resident |
| Affiliation |
Maulana azad medical college |
| Address |
Room No 204, Maulana Azad Medical College, Bahadur Shah Zafar Marg
New Delhi
DELHI
110002
India |
| Phone |
63777669098 |
| Fax |
|
| Email |
Shivrajchoudhary2012@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur Shah Zafar Marg, New Delhi |
| Type of Sponsor |
Government 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 |
| Shivraj Choudhary |
Maulana Azad Medical College |
Room No 204 Maulana Azad Medical College Bahadur Shah Zafar Marg
New Delhi
DELHI |
6377766908
shivrajchoudhary2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad medical college institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
First diagnosed at the time of admission with qSOFA score equals or more than 2 points according to sepsis 3 criteria
no clinical suspicion of infection |
|
| ExclusionCriteria |
| Details |
Known cases of
Acute coronary syndrome
Acute burn injuries
Terminal cancer
Estimated Glomerular filtration rate less than 60ml per min |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum Presepsin, PCT and IL-6 in adults with sepsis and non infectious organ failure. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| best predictor of outcome among Serum Presepsin, PCT and IL-6 in adults with sepsis |
6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
31/07/2025 |
| 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
|
This study will be done to find diagnostic and prognostic significance of Presepsin, Procalcitonin and Interleukin-6 in sepsis. |