| CTRI Number |
CTRI/2025/12/099128 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
13/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Neutrophil to lymphocyte ratio vs Sequential organ failure Assessment |
|
Scientific Title of Study
|
Neutrophil to lymphocyte ratio vs Sequential organ failure assessment (sofa) scores as marker of organ dysfunction severity in patients with sepsis in the ICU. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shankar Singh Shekhawat |
| Designation |
Junior resident |
| Affiliation |
Defence |
| Address |
Command hospital central Command Lucknow
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
07807263229 |
| Fax |
|
| Email |
shankarsingh1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shankar Singh Shekhawat |
| Designation |
Junior resident |
| Affiliation |
Defence |
| Address |
Command hospital central Command Lucknow
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
07807263229 |
| Fax |
|
| Email |
shankarsingh1111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shankar Singh Shekhawat |
| Designation |
Junior resident |
| Affiliation |
Defence |
| Address |
Command hospital central Command Lucknow
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
07807263229 |
| Fax |
|
| Email |
shankarsingh1111@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Purushotham Godavarthy |
| Address |
Command hospital central Command Lucknow |
| Type of Sponsor |
Research institution |
|
|
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 Shankar Singh Shekhawat |
ICU CHCC |
Command hospital central Command Lucknow
Lucknow
UTTAR PRADESH |
07807263229
shankarsingh1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee command hospital central Command Lucknow -226002(UP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with sepsis based on Sepsis-3 criteria |
|
| ExclusionCriteria |
| Details |
Immunocompromised state
Chronic organ dysfunction
Refusal of consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome measures will be recorded. |
0, 24 hrs,48hrs,72hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access the correlate NLR values with SOFA scores at ICU admission. To evaluate the predictive value of NLR & SOFA scores for ICU outcomes. |
0,24hrs,48hrs,72hrs |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
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
|
Sepsis is a life-threatening condition characterized by organ dysfunction due to a dysregulated host response to infection. It remains a leading cause of morbidity and mortality in ICU settings worldwide. Early detection of organ dysfunction is crucial for improving outcomes. SOFA score is established tool for assessing severity but involves multiple parameters. NLR derived from routine blood tests, is emerging as a simpler, faster marker. Comparing these tools may help identify a cost-effective method for sepsis management. |