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临床试验/NCT05925348
NCT05925348招募中不适用

Effect of Endotoxinemia on the Incidence of Postoperative Vasoplegia or Vasoplegic Shock Following Cardiothoracic Surgery Using Cardiopulmonary Bypass

Universität Münster1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Norepinephrine equivalent dose (NED)

研究概览

简要总结

This observational study investigates the effect of endotoxinemia on the postoperative incidence of vasoplegia or vasoplegic shock in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.

详细描述

Through previous research, it has been well established that cardiothoracic surgery using cardiopulmonary bypass (CPB) causes a systemic inflammatory response. This is in part due to the surgical trauma, the extracorporeal circulation and factors that come with it (e.g. blood contact with foreign surfaces, mechanical stress etc.), and ischemia. This inflammatory response is a key contributor to the incidence of vasoplegia and vasoplegic shock following these types of surgery - a common complication that in turn causes significant morbidity and mortality. Over the years, many factors that contribute to this reaction have been discussed. One potential explanation is the release of endotoxin into the bloodstream during CPB. Endotoxin is a molecule that is a part of bacteria which are native to the human gut. In healthy subjects, cell-barriers prevent release of relevant amounts of endotoxin into the blood stream. During major interventions, and especially during cardiac surgery with CPB, this barrier function is impeded, allowing endotoxin levels to rise and potentially exert detrimental effects. While previous studies have indicated that endotoxin may in fact be released into the bloodstream in significant concentrations, and there are some mechanistic explanations to how endotoxin may contribute to the resulting inflammation and vasoplegia, available studies have been small and the evidence is inconclusive. This study aims to show whether different blood-levels of endotoxin are associated with vasoplegia and vasoplegic shock in patients undergoing cardiac surgery with CPB.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients undergoing cardiac surgery requiring CPB
  • written informed consent

排除标准

  • emergency surgery in the context of acute coronary syndrome
  • patients with chronic inflammatory diseases of the gut
  • patients receiving immunosuppressive drugs
  • patients with infectious endocarditis
  • patients with sepsis
  • patients with chronic kidney disease with estimated glomerular filtration rate (eGFR) <20 ml/min/1,73m²
  • persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
  • persons held in an institution by legal of official order -

结局指标

主要结局

Norepinephrine equivalent dose (NED)

时间窗: within 24 hours following induction of general anesthesia

次要结局

  • Fluid balance(within 24 hours following induction of general anesthesia)
  • Duration of mechanical ventilation(within 72 hours after cardiac surgery)
  • Fluid input(within 24 hours following induction of general anesthesia)
  • Occurence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria(72 hours after cardiac surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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