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临床试验/CTRI/2025/03/081837
CTRI/2025/03/081837尚未招募不适用

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

Kasturba Medical College, Mangalore1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2025年3月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
138
试验地点
1
主要终点
The systemic inflammatory markers SIRI, SII, PIV, NLR, MLR, PLR can be used as an early indicator of Sepsis in PICU

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Patients admitted with severe life-threatening complications other than sepsis.
  • Patients on long term medications including but not limited to antibiotics.
  • Not willing to participate.

结局指标

主要结局

The systemic inflammatory markers SIRI, SII, PIV, NLR, MLR, PLR can be used as an early indicator of Sepsis in PICU

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Sahajanya Srikanth

Kasturba Medical College, Mangalore

研究点 (1)

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