跳至主要内容
临床试验/CTRI/2025/04/084940
CTRI/2025/04/084940尚未招募不适用

Prognostic value of IL-6 in SIRS- A Prospective observational study

PRS Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年4月23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
250
试验地点
1
主要终点
Mortality

研究概览

简要总结

This is a single centre prospective observational study regarding prognostic value of Interleukin-6 among patients with systemic inflammatory response syndrome presenting to ICU of a tertiary care centre.

IL-6 is considered to play an important role as an early indicator of inflammatory response. It is expected that monitoring of such inflammatory parameters would allow to identify the acute moment of the disease and chances of further clinical worsening.

In our study, all study patients will undergo standard treatment according to the discretion of treating physician and study related data will be collected in case record form. Close monitoring of clinical course along with laboratory parameters including biomarkers( Interleukin -6, Procalcitonin, C- reactive protein) will be done till date of discharge from ICU. Detailed analysis will be performed regarding biomarker values with 28 day mortality along with comparison of IL6 value with incidence or onset of organ dysfunction, need for mechanical ventilation and its duration, need for renal replacement therapy with or without cytokine filter, need for vasoactive agents or ECMO, duration of ICU stay.

With increasing mortality rates in patients with hyper inflammatory states including septic shock, if role of IL-6 in prognostication can be shown it could pave path for early therapy targeted at reducing inflammatory markers which could in turn help in reducing morbidity as well as mortality.

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

  • All patients admitted to our ICU who gave informed consent for the study meeting
  • SIRS criteria with suspected or confirmed sepsis and /or
  • Presenting in Shock.

排除标准

  • Children less than 18 years of age 2.Patients on long term steroid therapy or immunosuppressive agents
  • Pregnant women 4.Diagnosed cases of congenital or acquired immunodeficiency.

结局指标

主要结局

Mortality

时间窗: 28 days

次要结局

  • Comparison of IL-6 values to determine(1.Incidence or onset of organ dysfunction)

研究者

发起方
PRS Hospital
申办方类型
Private hospital/clinic

研究点 (1)

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