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临床试验/CTRI/2025/09/094403
CTRI/2025/09/094403尚未招募不适用

Evaluation of Procalcitonin and C-Reactive Protein as a prognostic marker among Sepsis patients in Oncology ICU

All India Institute of Medical Sciences New Delhi2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2025年9月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
153
试验地点
2
主要终点
Mortality at Day 28 from the inclusion of study

研究概览

简要总结

Adult patients  admitted in oncology ICU aged > 18 will be screened for sepsis as SOFA score > 2. The Primary objectiveis to evaluate PCT and CRP as a marker in predicting mortality among sepsis patients in oncology ICU ; our  Secondary objective is to assess the correlation of  PCT and CRP with SOFA score in predicting severity of disease. and to assess the correlation of PCT and CRP with length of ICU stay. PCT, CRP  will be measured on Day 0, 2 and 4. Patients  will be followed up for a mortality, duration of ICU stay and recovery. At 28 th day  patient/ patient’s attender will be called telephonically to assess for mortality or recovery. The discriminant performance of Day 0, 2, and 4 values of CRP and PCT in predicting within 28-day mortality will be assessed using the ROC curve analysis. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) will be calculated.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 69.00 Year(s)(—)
性别
All

入选标准

  • Sequential organ failure assessment score more than or equal to 2.

排除标准

  • 1.Refusal for participation in the study 2.Autoimmune diseases 3.Postoperative patients (upto postoperative day 3) 3.Recent Myocardial Infection 4.Pregnant patients.

结局指标

主要结局

Mortality at Day 28 from the inclusion of study

时间窗: Mortality at 28 th day from the inclusion of study

次要结局

  • Duration of ICU stay from the day of inclusion in the study to discharge/death(SOFA score at Day 0 ,2 & 4 from the day of inclusion in the study)

研究者

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Subalakshmi

All India Institute of Medical Sciences,New Delhi

研究点 (2)

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