Comparison of complete blood count and peripheral smear with procalcitonin and C reactive protein in diagnosis and prognostication of community acquired bacterial sepsis: A multicenter study in lower-middle income country
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To compare to diagnostic accuracy of components of CBC-PS (Hb, PC, TLC, DLC, Bn, My, MMy, TG, and D; and relevant ratios) with PCT and CRP in bacterial sepsis and non-infective SIRS.
研究概览
简要总结
Comparison of components complete blood count and peripheral smear with procalcitonin and C- reactive protein in diagnosis and prognostication of community acquired bacterial sepsis.
It is a multi centre study to be conducted in lower middle income country (India). Prospective paired design cohort analysis to be carried in multi speciality in ICU of two tertiary care hospital in LMIC in patients aged 16-85 years over 18 months with sample size of 200 patients.
Objectives:To Compare diagnostic accuracy of components of CBC -PS with PCT and CRP in bacterial sepsis and non infective SIRS.
To analyse the combination of components of CBC-PS for differentiating bacterial sepsis from NI-SIRS
To compare CBC-PS with procalcitonin and CRP on day 1 and day 4 of admission in predicting 30 day mortality in patients with Bacterial sepsis.
To evaluate correlation of CBC-PS with severity of illness and compare it with PCT and CRP in patients with bacterial sepsis.
Outcome- To compare the sensitivity and specificity of CBC-PS components with PCT and CRP in Bacterial sepsis and NI-SIRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient presenting to ICU with community acquired bacterial sepis from ER or hospital stay less than 24hrs meeting more than or equal to 2 SIRS criteria will be evaluated for inclusion into bacterial sepsis (S-SIRS) or NI- SIRS group.
- •2.Unconfirmed etiologies of SIRS will be included in the study subject in case of positive culture reports.
排除标准
- •1.Hospitalization in last 3 months 2.Immediate post-operative status 3.Pregnancy 4.Immunosuppressants 5.Immunocompromised states like AIDS 6.Immune-deficiency disorders 7.Haematological malignancies 8.Patients with known or suspected non-bacterial causes of SIRS like fungal, viral, rickettsial, and parasitic infections.
结局指标
主要结局
To compare to diagnostic accuracy of components of CBC-PS (Hb, PC, TLC, DLC, Bn, My, MMy, TG, and D; and relevant ratios) with PCT and CRP in bacterial sepsis and non-infective SIRS.
时间窗: Within 2 hours of admission
次要结局
- To analyze the combination of components of CBC-PS differentiating bacterial(sepTo calculate the correlation coefficient of components of CBC-PS with APACHE II and compare it with PCT and CRP in patients of bacterial sepsis from NI-SIRS.)
- To compare CBC-PS with Procalcitonin and CRP on day 1 and day 4 of admission in predicting 30-day mortality in patients of bacterial sepsis.(30 day of admission)
- To evaluate correlation of CBC-PS with severity (APACHE And SOFA) of illness and compare it with PCT and CRP in patients of bacterial sepsis(Admission (Day1) and on day 4)
研究者
Dr Ruchi Gupta
Holy Family Hopsital