| CTRI Number |
CTRI/2025/11/096981 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of blood cell ratios as markers of infection severity in patients with sepsis |
|
Scientific Title of Study
|
A comparative study of Neutrophil to lymphocyte ratio, Platelet to lymphocyte ratio, and mean platelet volume to platelet count ratio as biomarkers in patients with sepsis assessed using qSOFA and APACHE2 criteria |
| Trial Acronym |
SEPBIOMARK |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubham deepak gonjari |
| Designation |
Primary DNB Resident (General medicine) |
| Affiliation |
Metrounited healthcare, shivamogga |
| Address |
Metrounited healthcare hospital, shivmurthy circle, savalanga road, jayanagar, shivamogga, karnataka
Shimoga
KARNATAKA
577201
India |
| Phone |
9130467535 |
| Fax |
|
| Email |
shubhamgonjari1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pruthvi B C |
| Designation |
Medical director ,MD General medicine |
| Affiliation |
Metrounited healthcare, shivamogga |
| Address |
Metrounited healthcare hospital, shivmurthy circle, savalanga road, jayanagar, shivamogga, karnataka
Shimoga
KARNATAKA
577201
India |
| Phone |
9448064080 |
| Fax |
|
| Email |
drpruthvibc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham deepak gonjari |
| Designation |
Primary DNB Resident (General medicine) |
| Affiliation |
Metrounited healthcare, shivamogga |
| Address |
Metrounited healthcare hospital, shivmurthy circle, savalanga road, jayanagar, shivamogga, karnataka
Shimoga
KARNATAKA
577201
India |
| Phone |
9130467535 |
| Fax |
|
| Email |
shubhamgonjari1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Metrounited Healthcare |
| Address |
Metrounited healthcare, shivmurthy circle, savalnga road , jayanagar, shimoga, pin-577201 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Pruthvi B C |
Metrounited healthcare shimoga |
Shivmurthy circle, savlanga road, jayanagar, shivamogga
Shimoga
KARNATAKA |
9448064080
drpruthvibc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board of SANKARA EYE HOSPITAL, SHIVAMOGGA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
any patient with age more than 18 yr and in sepsis |
|
| ExclusionCriteria |
| Details |
age less than 18 years
corticosteroid therapy
antibiotics use before admission
hematological disorder
malignant disease
chemotherapy or radiotherapy 1 month before |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Predictive performance of baseline Neutrophil to lymphocyte ratio, Platelet to lymphocyte ratio, and Mean platelet volume to platelet count ratio for 28 day all cause mortality in patients with sepsis |
baseline biomarker measurements- within 24 hours of hospital admission
primary endpoint assessment- 28 days after enrolment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 28 day mortality OR ICU admission OR need for vasopressors / mechanical ventilation can also be predicted |
28 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/11/2025 |
| 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
|
thos prospective observational cross sectional study aims to evaluate and compare the diagnostic and prognostic utility of NLR and MPV/P as biomarkers in patients with sepsis and to correlate this markers with established clinical severity scores qSOFA and APACHE 2 at tertiary care hospital primary outcome will be 28 day all cause mortality and secondary outcome will be need for vasopressors support , duration of ICU stay and correlation of biomarkers trends with qSOFA and APACHE 2 scores |