跳至主要内容
临床试验/NCT04669444
NCT04669444进行中(未招募)不适用

Investigation of Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
1
主要终点
Change in plasma IL-6 level from baseline to low driving pressure ventilation

研究概览

简要总结

Patients in end-stage cardiac failure and/or respiratory failure may be started on a rescue therapy known as Extracorporeal Membrane Oxygenation (ECMO). One of the major clinical questions is how to manage the ventilator when patients are on ECMO therapy. Ventilator Induced Lung Injury (VILI) can result from aggressive ventilation of the lung during critical illness. VILI and lung injury such as Acute Respiratory Distress Syndrome (ARDS) can further increase the total body inflammation and stress, this is known as biotrauma. Biotrauma is one of the mechanisms that causes multi-organ failure in critically ill patients. One advantage of ECMO is the ability to greatly reduce the use of the ventilator and thus VILI by taking control of the patient's oxygenation and acid-base status. By minimizing VILI during ECMO we can reduce biotrauma and thus multi-organ failure. Since the optimal ventilator settings for ECMO patients are not known, we plan to study the impact of different ventilator settings during ECMO on patient's physiology and biomarkers of inflammation and injury.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • •Patient currently on ECMO (Veno-Venous or Venous-Arterial or Venous-Arterial-Venous)
  • •Patient that is a potential ECMO candidate.

排除标准

  • •History of Lung or Cardiac Transplantation
  • •Patient is not committed to full support
  • •Treating clinician refusal, or unwillingness to commit to controlled ventilation for at least 4-6 hours (if patient is mechanically ventilated)
  • •Inability to get informed consent from the patient or surrogate.

研究组 & 干预措施

Low Driving Pressure Protocol

Experimental

The patients ventilator driving pressure will be decreased (as tolerated by the patient) for 2 hours while on extracorporeal membrane oxygenation (ECMO) support.

干预措施: Ventilator (Device)

结局指标

主要结局

Change in plasma IL-6 level from baseline to low driving pressure ventilation

时间窗: 2 hours

IL-6 is a marker of systemic inflammation, previously used in studies of ECMO and ARDS.

次要结局

  • Change in plasma sRAGE from baseline to low driving pressure ventilation(2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert L. Owens

Associate Professor, Medicine

University of California, San Diego

研究点 (1)

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