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临床试验/CTRI/2026/03/105167
CTRI/2026/03/105167尚未招募不适用

Efficacy of pancreatic stone proteins in early diagnosis of sepsis and comparison of its temporal trends with ESR and CRP - A longitudinal observational study

Jawaharlal Nehru Medical College1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2026年3月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
53
试验地点
1

研究概览

简要总结

WHO defines sepsis a life-threatening condition that arises when the body’s response to infection causes injury to its own tissues and organs.Sepsis remains a significant cause of morbidity and mortality in the paediatric population. Early detection is crucial for effective management, prompting ongoing research into reliable biomarkers. Traditionally, biomarkers such as Erythrocyte Sedimentation Rate (ESR) and C- Reactive Protein (CRP) have been utilised, but their specificity and sensitivity limitations have led to the exploration of novel indicators like Pancreatic Stone Proteins (PSP). Pancreatic stone protein (PSP), a C-type lectin protein, is a well-defined biomarker of sepsis. PSP activates polymorphonuclear neutrophils (PMNs) and aggravates multiple organ dysfunction syndrome. PSP levels are correlated with disease severity, vasopressor support, progression to organ failure, mechanical ventilation, renal replacement therapy, length of stay, and mortality. As PSP is a C-type lectin protein, it may have a role in activating innate immunity through the C-type lectin receptors (CLRs) of the study.Through this study, we aim to evaluate the diagnostic value of PSP in Indian paediatric age group, its evolving levels throughout the course of the disease and how it compares to other pre-existing markers. Existing biomarkers have proven to have a variable sensitivity in early course of sepsis, with their elevation observed in non-septic SIRS as well. There is a wide knowledge gap in early detection of sepsis, with the only diagnostic modality being a positive blood culture. As a confimatory blood culture requires a standard incubation time of 5 days, to develop a diagnostic test for confirmation of sepsis onset early on becomes pivotal in improving the existing prognostic outcomes.

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

  • Children aged 1 month to 18 years admitted to specified units presenting with sepsis symptoms per the International Paediatric Sepsis Consensus Conference (IPSCC) guidelines.
  • 2024, which recommends that sepsis can be identified in children with a phoenix sepsis score of more than 2 or, sepsis confirmed by a positive blood culture isolate.

排除标准

  • Patients with functional disorders unrelated to sepsis (autoimmune disorders, malignancies, non-infectious SIRS causes)
  • Patients with surgery in past 6 months.
  • Patients with underlying renal, cardiac or hepatic failure.

研究者

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

Paras Singh

Jawaharlal Nehru Medical College

研究点 (1)

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