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临床试验/NCT05542966
NCT05542966进行中(未招募)不适用

Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress and Organ Injury

Australian and New Zealand Intensive Care Research Centre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Super oxide dismutase levels U/ml

研究概览

简要总结

To compare the impact of liberal vs conservative oxygen doses on markers of oxidative stress in patients enrolled in the BLENDER trial.

详细描述

Extracorporeal membrane oxygen (ECMO) is a heart lung support device used for patients with severe and cardiac and respiratory failure and carries an increased risk of exposure to very high oxygen tensions. Hyperoxia (arterial oxygen >100mmHg) can lead to the production of reactive oxygen species (ROS). Excess production of ROS and depletion of antioxidant compounds is referred to as oxidative stress and results in inflammation, tissue injury and cell death. The inter-relationship between the production of ROS and end organ dysfunction is complicated and remain unclear. A more detailed assessment of the timing of changes in markers of oxidative stress, inflammatory mediators and tissue injury is warranted to understand the processes and potentially identify therapeutic targets.

The BLENDER Trial is a multicentre trial in ECMO patients to determine whether a conservative oxygen strategy during ECMO reduces ICU length of stay and improves patient outcomes compared to a liberal oxygen strategy. Currently there have been no studies that look at the underlying pathophysiological changes that occur in patients on ECMO when subjected to different oxygen concentrations. As such The BLENDER study represents a unique opportunity to understand the mechanisms by which hyperoxia may cause tissue injury in patients receiving ECMO. This nested study seeks to elucidate whether exposure to hyperoxia during ECMO results in increased oxidative stress and whether this is correlated with increased risk of tissue injury and organ dysfunction. A better understanding of the mechanism of hyperoxia induced tissue injury may allow treatment to be optimised for patients exposed to hyperoxia as part of their treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving venoarterial (VA) ECMO
  • Enrolled in the BLENDER trial

排除标准

  • Not enrolled in the BLENDER trial

结局指标

主要结局

Super oxide dismutase levels U/ml

时间窗: Within 24 hours of ECMO commencement

Plasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO

次要结局

  • Marker of Neurological Injury(Day 7 of ECMO)
  • Coagulation Parameters(Day 7 of ECMO)
  • Immune Markers(Day 7 of ECMO)
  • Markers of Kidney Injury(Day 7 of ECMO)
  • Marker of Cardiac Injury(Day 7 of ECMO)
  • Other Markers of Oxidative Stress(Day 7 of ECMO)
  • Superoxide dismutase levels(On Day 7 following ECMO commencement)
  • Markers of Liver Injury(Day 7 of ECMO)
  • Superoxide dismutase levels U/ml(On Day 3 following ECMO commencement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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