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临床试验/NCT06993467
NCT06993467已完成不适用

Oxygen Delivery During Cardiopulmonary Bypass And Inflammatory Reaction After Cardiac Surgery

Azienda Ospedaliero, Universitaria Ospedali Riuniti2 个研究点 分布在 1 个国家目标入组 908 人开始时间: 2023年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
908
试验地点
2
主要终点
SIRS

研究概览

简要总结

Cardiac surgery, especially when involving cardiopulmonary bypass (CPB), has long been associated with a systemic inflammatory response that can lead to a range of complications, from mild symptoms to severe organ dysfunction, and mortality. The exact mechanisms behind this response remain a topic of extensive research, but it's clear that the body's reaction to the extracorporeal circulation, combined with surgical trauma, plays a significant role. Factors such as genomics, age, specific preoperative conditions, and the duration of operations have been associated with significant clinical responses.

A pivotal insight into this response comes from recent genome-wide transcriptional analyses. Perioperative ischemia and ischemia-reperfusion injury (IRI) have been suggested as hub-nodes in a hierarchic structure evaluating the response to cardiac surgery. This suggests that IRI isn't just a side effect of the surgery but might be a central player in the body's inflammatory response. The role of perioperative ischemia and its potential as a significant contributor to the postoperative inflammatory response cannot be understated. This study aims to delve deeper into the role of oxygen delivery and its implications in the systemic inflammatory response post- cardiac surgery.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients (18-90 years)
  • •Elective surgery
  • •CPB-assisted

排除标准

  • •Age < 18 or > 90 years
  • •Infective endocarditis
  • •Hypothermia during surgery (<34°C)
  • •Emergency surgery

结局指标

主要结局

SIRS

时间窗: 12 hours after surgery

Systemic Inflammatory Reaction Syndrome (SIRS) as per the 1991 American College of Chest Physicians/Society of Critical Care Medicine criteria

次要结局

  • Composite outcome(Up to 30 days)

研究者

发起方
Azienda Ospedaliero, Universitaria Ospedali Riuniti
申办方类型
Other
责任方
Principal Investigator
主要研究者

Enrico Squiccimarro

Dr

Azienda Ospedaliero, Universitaria Ospedali Riuniti

研究点 (2)

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