跳至主要内容
临床试验/CTRI/2021/02/031517
CTRI/2021/02/031517招募中不适用

Observational study to assess inflammatory biomarker profile in Patients undergoing surgery

Zum Heilen Diagnostic Therapeutics ZH DT1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
1.To assess and correlate the pattern of IL-6, TNF-α, IFN-γ, MIP1α, MIP1β, MCP1, IP-10, IL-1β during the post-operative septic conditions from baseline to end of study

研究概览

简要总结

Uncheckedsepsis in patients during post-surgical conditions has become a major riskfactor for mortality. In a study conducted in an Indian tertiary hospital, itwas observed that ICU mortality, hospital mortality, and 28-day mortality were56%, 63.6%, and 62.8%, respectively (Chatterjee et al., 2017). This further shows the how critical isthe requirement for detection and monitoring of sepsis in patients whounderwent surgical procedures. In order to regulate the mortality rates causedby surgical sepsis, new approaches which could be precise, faster and costeffective must have to be inculcated in the field of medical health care. So,the early detection of sepsis by assessment of inflammatory markers in bloodsamples from patients with post-surgical conditions via RT-PCR has beenproposed in this study. 3ml peripheral vein blood will be collected with EDTAK2anticoagulant; serum and plasma will be separated.1.5ml of saliva will becollected using saliva collector. All types of samples will be collected on day0, day 3 and day 5. IL-6, TNF-α, IFN-γ, MIP1α, MIP1β, MCP1, IP-10, IL-1β will be theinflammatory markers that will be assessed by RT-PCR.

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •1.Age group 19 – 70 yrs 2.Both male and females involved 3.Patients who underwent major and minor surgical procedures along with diabetic foot, necrotizing fasciitis, abdominal sepsis will be included in the study 4.Subjects who are willing to provide written consent for the study 5.Subject willing to abide by and comply with the study protocol.

排除标准

  • •1.Patients above 70yrs old 2.Pregnancy and lactation 3.Other health conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.

结局指标

主要结局

1.To assess and correlate the pattern of IL-6, TNF-α, IFN-γ, MIP1α, MIP1β, MCP1, IP-10, IL-1β during the post-operative septic conditions from baseline to end of study

时间窗: Day 0,Day 3and Day 5

次要结局

  • 1.To identify the pattern of expression of inflammatory markers during the prognosis of the septic conditions(Day 0,Day 3and Day 5)

研究者

发起方
Zum Heilen Diagnostic Therapeutics ZH DT
申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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