跳至主要内容
临床试验/NCT04678518
NCT04678518Unknown不适用

Inflammatory Markers Dynamics in Response to Extra-corporeal Membrane Oxygenator Decannulation

Hamad Medical Corporation1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Cytokine changes

研究概览

简要总结

Extracorporeal membrane oxygenation (ECMO) aim at providing cardiac, respiratory support, or both. The use of ECMO could be associated with systemic inflammatory response syndrome (SIRS) at the time of initiation or the time of decannulation. There is an existing evidence to state that clinical criteria of SIRS accompany decannulation. We aim at proving this relation through studying the inflammatory markers changes before and after decannulation. The investigators will study all participants who require ECMO support in the heart hospital, all patient will be subjected to clinical evaluation of the SIRS criteria plus studying the inflammatory makers that will include IL1, IL2, IL6 and TNF before and after decannulation. Participants will be divided based on the SIRS criteria into 2 groups and both groups will be compared using Chi-Square analysis (Fisher tests if small sample size) or two tailed t-test, as appropriate

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ALL ECMO patients candidates for decannulation

排除标准

  • •patients who have identified sepsis prior to decannulation, febrile patients, patient who receive steroids and patient who die within 48 hours after ECMO decannulation.

研究组 & 干预措施

SIRS

Active Comparator

Patients will be grouped according to the presence or absence of SIRS criteria into group I (SIRS)

干预措施: Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF (Diagnostic Test)

NON-SIRS

Placebo Comparator

Patients will be grouped according to the presence or absence of SIRS criteria into group II (Non-SIRS)

干预措施: Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF (Diagnostic Test)

结局指标

主要结局

Cytokine changes

时间窗: 2 years

Cytokines changes: Interleukins (IL); IL1, IL2, IL6 and TNF 1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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