| CTRI Number |
CTRI/2025/03/081837 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of systemic inflammatory indicators NLR, PLR, MLR, SII,SIRI and PIV as an early indicator for sepsis in PICU |
|
Scientific Title of Study
|
ROLE OF SYSTEMIC INFLAMMATORY INDICES SUCH AS NLR, PLR, MLR, SII, SIRI AND PIV IN EARLY IDENTIFICATION
SEPSIS IN PICU PATIENTS IN COASTAL DISTRICT OF DAKSHINA KANNADA-
A PROSPECTIVE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahajanya Srikanth |
| Designation |
MBBS |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, Mangalore, 203, Light house hill road, Hampankatta, Mangalore, 575001 #27, Sri Sai, Syndicate Bank Colony, Opposite Kamakshipalya Police Station, Off Magadi Main Road, Bangalore 560079 Dakshina Kannada KARNATAKA 575001 India |
| Phone |
7022089289 |
| Fax |
|
| Email |
sahajanya.srikanth@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Sahajanya Srikanth |
| Designation |
MBBS |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, Mangalore, 203, Light house hill road, Hampankatta, Mangalore, 575001 #27, Sri Sai, Syndicate Bank Colony, Opposite Kamakshipalya Police Station, Off Magadi Main Road, Bangalore 560079 Dakshina Kannada KARNATAKA 575001 India |
| Phone |
7022089289 |
| Fax |
|
| Email |
sahajanya.srikanth@learner.manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Sahajanya Srikanth |
| Designation |
MBBS |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, Mangalore, 203, Light house hill road, Hampankatta, Mangalore, 575001 #27, Sri Sai, Syndicate Bank Colony, Opposite Kamakshipalya Police Station, Off Magadi Main Road, Bangalore 560079 Dakshina Kannada KARNATAKA 575001 India |
| Phone |
7022089289 |
| Fax |
|
| Email |
sahajanya.srikanth@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Mangalore |
| Address |
203, Lighthouse Hill road, Hampankatta, Mangalore, 575001 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gayathri Renganathan |
RAPCC HOSPITAL |
Government Wenlock Hospital, Hampankatta, Mangalore, 575001 Dakshina Kannada KARNATAKA |
9632866222
gayathri.renganathan@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, KMC, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A418||Other specified sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Complete Blood Count |
CBC reports of all the patients admitted to the PICU has been collected to calculate the Systemic Inflammatory Indices. No drugs, treatment or other tests were done for the study |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All children fulfilling the criteria of sepsis and septic shock admitted to PICU according to the 3rd International Consensus Definition of 2016, during the study period |
|
| ExclusionCriteria |
| Details |
1. Patients admitted with severe life-threatening complications other than sepsis.
2. Patients on long term medications including but not limited to antibiotics.
3. Not willing to participate. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The systemic inflammatory markers SIRI, SII, PIV, NLR, MLR, PLR can be used as an early indicator of Sepsis in PICU |
This decreases the need for waiting for the blood cultures for the diagnosis of sepsis and can help to decrease the turn over time significantly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of sepsis to decide the mode of treatment and preferred antibiotics |
We aim to eliminate the time taken for cultures. With early treatment with antibiotics we can achieve better prognosis |
|
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Target Sample Size
|
Total Sample Size="138" Sample Size from India="138"
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)
|
17/03/2025 |
| 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="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 prospective observational study, conducted at Kasturba Medical College, Mangalore, aims to evaluate the role of systemic inflammatory indices in the early identification of sepsis among Pediatric Intensive Care Unit PICU patients in the coastal district of Dakshina Kannada. Sepsis is a leading cause of pediatric morbidity and mortality worldwide, particularly in low and middle-income countries, where delayed diagnosis contributes significantly to poor outcomes. While blood culture remains the gold standard for sepsis diagnosis, it has a turnaround time of 48–72 hours, making early detection challenging. Given the need for a rapid, reliable, and accessible bedside diagnostic tool, this study seeks to determine the predictive value of systemic inflammatory markers such as Systemic Immune Inflammatory Index SII, Systemic Inflammation Response Index SIRI, Pan Immune Inflammation Value PIV, Neutrophil to Lymphocyte Ratio NLR, Monocyte to Lymphocyte Ratio MLR, and Platelet to Lymphocyte Ratio PLR in identifying pediatric sepsis.
The study will be conducted over a period of three months at RAPCC Hospital, Mangalore, using a prospective observational design with a total sample size of 138 patients, 69 with sepsis and 69 controls without sepsis. Patients will be categorized based on sepsis criteria as per the Third International Consensus Definition of 2016, which defines sepsis as a suspected or confirmed infection accompanied by an acute increase of 2 or more SOFA Sequential Organ Failure Assessment points. Data will be collected from patient medical records, and systemic inflammatory markers will be calculated using laboratory reports. The statistical analysis will be performed using IBM SPSS Version 29.0, where descriptive statistics, independent sample t-tests, ROC Receiver Operating Characteristic analysis, and Youden Index will be used to determine the diagnostic accuracy of the inflammatory indices.
Ethical clearance has been obtained from the Institutional Ethics Committee of Kasturba Medical College, Mangalore, and additional permission has been secured from the District Medical Officer DMO, RAPCC Hospital. Informed consent will be obtained from parents or guardians before enrolling patients in the study. The potential implications of this research are significant, as early identification of sepsis using systemic inflammatory indices could reduce reliance on delayed culture reports, allow for earlier intervention, improve patient outcomes, and ultimately decrease pediatric morbidity and mortality. The study also aims to fill a critical knowledge gap, as there are limited studies evaluating the use of these systemic inflammatory markers in the Indian pediatric population. If successful, the findings could support the integration of these markers into routine clinical practice, enhancing the ability of healthcare providers to diagnose and treat sepsis more effectively in resource-limited settings. |