Меню
Идёт набор NCT05833828

Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery

— Наблюдательное Vasoplegia Vasoplegic Shock

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: on-pump surgery, off-pump surgery.
Кому может быть актуально
Состояния в реестре: Vasoplegia, Vasoplegic Shock. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

  • Процедура on-pump surgery
    the surgery will be performed "on-pump"
  • Процедура off-pump surgery
    the surgery will be performed "off-pump"

Первичные конечные точки

  • Differences in plasma concentration of Angiotensinogen [Срок оценки: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Renin [Срок оценки: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Angiotensin I [Срок оценки: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Angiotensin converting enzyme (ACE) [Срок оценки: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Angiotensin II [Срок оценки: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Aldosterone [Срок оценки: between induction of anesthesia and immediately after surgical intervention]
Вторичные конечные точки (5)
  • Differences in plasma concentration of Angiotensin 1-9 [Срок оценки: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Angiotensin 2-7 [Срок оценки: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Dipeptidyl-peptidase 3 (DPP3) [Срок оценки: between induction of anesthesia and immediately after surgical intervention]
  • Incidence of vasoplegia [Срок оценки: within 12 hours post surgery]
  • Cumulative dose of vasopressors [Срок оценки: within 12 hours post surgery]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 2 центра
  • Deutsches Herzzentrum der Charité — Berlin
  • University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pai — Münster

Идентификаторы

NCT: NCT05833828 · AnIt22-08

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗