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Идёт набор NCT07324694

Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery

— Наблюдательное Cardiac Surgery Intraoperative Hemodynamic Instability Postoperative Complication Acute Kidney Injury

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Простыми словами

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

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Cardiac Surgery, Intraoperative Hemodynamic Instability, Postoperative Complication, Acute Kidney Injury. 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Impact of Intraoperative Hemodynamic Instability on Postoperative Major Adverse Events in Cardiac Surgery Patients: A Prospective Cohort Study

Обзор

Intraoperative hemodynamic instability (IOHI) is a common occurrence during cardiac surgery and is associated with organ hypoperfusion. However, the specific impact of IOHI on composite adverse outcomes remains unclear. This prospective cohort study aims to evaluate the association between intraoperative hemodynamic instability (defined as MAP \< 65 mmHg or vasopressor requirement) and major postoperative complications (Delirium, Acute Kidney Injury, Stroke, or Mortality) in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass.

Подробное описание

Hemodynamic instability during cardiac surgery is a critical factor influencing postoperative recovery. While transient hypotension is common, prolonged instability may lead to end-organ damage due to hypoperfusion. This prospective observational study will be conducted at the University of Health Sciences Gazi Yasargil Training and Research Hospital.

Patients scheduled for elective cardiac surgery (Coronary Artery Bypass Grafting, Valve replacement/repair, or combined procedures) utilizing cardiopulmonary bypass will be enrolled. Intraoperative hemodynamic data, including Mean Arterial Pressure (MAP), heart rate, and vasoactive medication requirements, will be recorded.

Patients will be categorized into two groups based on intraoperative stability:

1. Hemodynamic Instability Group: Patients experiencing MAP \< 65 mmHg for more than 5 minutes continuously or requiring significant vasopressor/inotropic support to maintain target pressure. 2. Stable Group: Patients maintaining hemodynamic stability without significant hypotensive episodes.

The primary endpoint is a composite of major adverse events within 30 days, including Postoperative Delirium (assessed via CAM-ICU), Acute Kidney Injury (KDIGO criteria), Stroke, and All-cause Mortality. Secondary endpoints include the duration of mechanical ventilation and length of ICU/hospital stay. The study aims to provide evidence-based thresholds for intraoperative blood pressure management to improve patient outcomes.

Первичные конечные точки

  • Incidence of Composite Adverse Events [Срок оценки: Up to 30 days post-operation]
Вторичные конечные точки (3)
  • Duration of Mechanical Ventilation [Срок оценки: Up to 30 days]
  • Length of Hospital Stay [Срок оценки: Up to 30 days]
  • Length of Intensive Care Unit (ICU) Stay [Срок оценки: Up to 30 days]

Критерии участия

Критерии включения

  • Patients aged 18 years or older.
  • Scheduled for elective cardiac surgery (CABG, Valve replacement/repair, or combined procedures).
  • Surgery performed under cardiopulmonary bypass (CPB).
  • Preoperative sinus rhythm.
  • Signed informed consent form.

Критерии исключения

  • Emergency or salvage surgery.
  • Off-pump coronary artery bypass grafting.
  • Preoperative mechanical circulatory support (IABP, ECMO) requirement.
  • Pre-existing chronic renal failure requiring dialysis (HD/PD).
  • Pre-existing cognitive impairment, dementia, or history of psychiatric disorders affecting cooperation.
  • Pregnancy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Gazi Yaşargil Training and Research Hospital — Diyarbakır

Публикации

  • Shen X, Tao H, Chen W, Sun J, Jin R, Zhang W, Hong L, Zhang C. Perioperative blood pressure variability as a risk factor for postoperative delirium in the patients receiving cardiac surgery. BMC Anesthesiol. 2024 Nov 25;24(1):424. doi: 10.1186/s12871-024-02817-x. PMID 39581994
  • D'Amico F, Fominskiy EV, Turi S, Pruna A, Fresilli S, Triulzi M, Zangrillo A, Landoni G. Intraoperative hypotension and postoperative outcomes: a meta-analysis of randomised trials. Br J Anaesth. 2023 Nov;131(5):823-831. doi: 10.1016/j.bja.2023.08.026. Epub 2023 Sep 20. PMID 37739903
  • Buitenwerf E, Boekel MF, van der Velde MI, Voogd MF, Kerstens MN, Wietasch GJKG, Scheeren TWL. The haemodynamic instability score: Development and internal validation of a new rating method of intra-operative haemodynamic instability. Eur J Anaesthesiol. 2019 Apr;36(4):290-296. doi: 10.1097/EJA.0000000000000941. PMID 30624247

Идентификаторы

NCT: NCT07324694 · GYTRH-KVC-IOHI-01

Первоисточники (государственные реестры)

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