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临床试验/CTRI/2025/09/093997
CTRI/2025/09/093997已完成不适用

Diagnostic validity of Prokineticin-2 compared to Procalcitonin and Blood culture in patients with sepsis

Jawaharlal Nehru Medical College1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年9月12日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Prokineticin-2 can be useful marker to diagnose sepsis effectively

研究概览

简要总结

Procalcitonin is used to diagnose sepsis in critically ill patients. But Procalcitonin is not specific to sepsis because it can be raised in cases of burns, trauma etc. Procalcitonin sensitivity and specificity are 64.7 percent and 50 percent on day 1 and   95.5 percent and 95.1 percent on 28-day mortality respectively. These factors lead to validate new sepsis marker that is, Prokineticin 2. Prokineticin-2 (PK-2) is considered a next generation inflammatory marker with superior diagnostic value. Prokineticin-2 sensitivity and specificity are 70.6 percent and 50 percent on day 1 and   98.4 percent and 95.5 percent on 28-day mortality respectively. As compared to traditional biomarkers, Prokineticin 2 can be more appropriate method to diagnose sepsis in patients

Procalcitonin PCT is used to diagnose sepsis in critically ill patients. Procalcitonin (PCT), a biomarker elevated in bacterial infections, has been extensively studied for its potential role in sepsis diagnosis. The diagnostic accuracy of Procalcitonin in identifying sepsis among adult patients admitted to emergency departments. the authors aimed to clarify the utility of PCT as a reliable diagnostic tool, addressing inconsistencies in previous research and providing updated evidence to guide clinical decision-making

NEED FOR STUDY

A study published in year 2025 by Bhat et.al pointed out that Procalcitonin was assessed through point of care testing in ICU whereas PK-2 was measured using ELISA test in laboratory therefore stating possibility that using two different methods for two biomarkers may have introduced variability and potential errors in results.

Therefore, keeping these points in view, we would like to assay Procalcitonin and Prokineticin-2 using ELISA and also want to compare diagnostic validity of Prokineticin-2 with procalcitonin and blood culture for diagnosing sepsis on early basis

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients with suspected of sepsis in IPD patients 2 Before antibiotic initiation, sample sent for Aerobic Bacterial Blood culture and Procalcitonin for the same patient 3 Estimation of Prokineticin-2 within 1 hour to prevent variability 4 Age 18 years or more.

排除标准

  • 1.Prior antibiotic therapy more than 24 hours before sample collection
  • Either of Blood culture or Procalcitonin investigation not advised
  • Negative Blood culture reported are excluded
  • Procalcitonin level less than or equal to cut off value 0.5ng/ml are excluded
  • Patients with autoimmune diseases, HIV, HBsAg, HCV are excluded.
  • Patients on long term steroids immunosuppressants chemotherapy or with terminal illness malignant cancer end-stage liver or renal disease are excluded.

结局指标

主要结局

Prokineticin-2 can be useful marker to diagnose sepsis effectively

时间窗: 1 year

次要结局

未报告次要终点

研究者

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

Ojas Kumar Aggarwal

Jawaharlal Nehru Medical College

研究点 (1)

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