跳至主要内容
临床试验/NCT05833828
NCT05833828招募中不适用

Differences in Plasma Concentration of RAAS-axis Hormones in Patients Undergoing Cardiac Surgery With or Without Cardiopulmonary Bypass

Universität Münster2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8月24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
40
试验地点
2
主要终点
Differences in plasma concentration of Renin

研究概览

简要总结

This study investigates the question of whether there are differences in the plasma concentration of hormones of the RAAS-axis between patients undergoing on-pump cardiac surgery and those receiving off-pump surgery

详细描述

In patients undergoing cardiac surgery, the occurrence of vasoplegia or vasoplegic shock is a common and sometimes very severe complication. Although there are multiple factors that may affect the incidence and severity of vasoplegia, it remains unclear which role the use of cardiopulmonary bypass may play in the pathogenesis of this complication. The heart normally pumps blood through the lungs where the blood primarily gets oxygenated. However, it is also known that pulmonary blood flow is also essential for the activation of various hormones, some of which are central to the regulation of vascular tension and blood pressure. If the pulmonary circulation is bypassed, as is the case in on-pump cardiac surgery, it is likely that the resulting differential activity of hormones may cause or contribute to the incidence of vasoplegia. This study aims to show whether cardiopulmonary bypass leads to the differential regulation of hormones of the renin-angiotensin-aldosterone-system which could explain why some patients suffer from vasoplegia or vasoplegic shock following such procedures.

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 on- or off-pump coronary artery bypass graft surgery
  • written informed consent

排除标准

  • emergency surgery in the context of acute coronary syndrome
  • ACE-inhibitor or Angiotensin 1 (AT1)-receptor-blocker intake that was not paused on the day of surgery
  • Chronic kidney disease with estimated glomerular filtration rate (eGFR)<30ml/min/1.73m²
  • Severe structural lung disease (asbestosis, silicosis, severe sarcoidosis, tuberculosis, severe emphysema, chronic obstructive pulmonary disease (COPD) Gold 3-4, lung fibrosis)
  • Chronic pulmonary hypertension
  • Pregnancy or breastfeeding
  • Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
  • Persons held in an institution by legal or official order

结局指标

主要结局

Differences in plasma concentration of Renin

时间窗: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Angiotensin converting enzyme (ACE)

时间窗: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Angiotensin I

时间窗: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Angiotensin II

时间窗: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Angiotensinogen

时间窗: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Aldosterone

时间窗: between induction of anesthesia and immediately after surgical intervention

次要结局

  • Differences in plasma concentration of Angiotensin 2-7(between induction of anesthesia and immediately after surgical intervention)
  • Differences in plasma concentration of Dipeptidyl-peptidase 3 (DPP3)(between induction of anesthesia and immediately after surgical intervention)
  • Incidence of vasoplegia(within 12 hours post surgery)
  • Cumulative dose of vasopressors(within 12 hours post surgery)
  • Differences in plasma concentration of Angiotensin 1-9(between induction of anesthesia and immediately after surgical intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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