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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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
 
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  
 
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.
 
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