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Набор скоро начнётся NCT07497139

Sepsis Induced Myocardial Injury in Critically Ill Children

— Наблюдательное Sepsis Induced Cardiomyopathy Sepsis Induced Myocardial Dysfunction

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: observational study.
Кому может быть актуально
Состояния в реестре: Sepsis Induced Cardiomyopathy, Sepsis Induced Myocardial Dysfunction. Базовые параметры: 1 мес. — 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
Египет
Следующий шаг
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Официальное название

Predictors and Outcome Of Sepsis Induced Myocardial Injury In Critically Ill Children; A Prospective Observational Study

Обзор

Sepsis is a dysregulated immune response due to infection, leading to life-threatening organ dysfunction affecting respiratory, renal, immunological, digestive, neurological, and cardiovascular organs. The prevalence of cardiovascular dysfunction caused by sepsis may reach up to 50%, and the symptoms may comprise vasodilatory shock, myocardial injury, arrhythmia, and sepsis-induced cardiomyopathy. (1) Sepsis-induced cardiomyopathy occurs frequently in critically ill patients, but the clinical features and prognostic impact of sepsis-induced cardiomyopathy on sepsis outcome remain controversial. Cardiac troponins I and T are regulatory proteins that control the calcium-mediated interaction of actin and myosin, producing myocardial contraction. Since troponins do not occur in extracellular space, their appearance in serum is sensitive and specific marker of myocardium damage. They have been established as the gold standard biochemical markers for myocardial necrosis . Elevated cardiac troponins levels have been detected in critically ill children with congenital heart disease before and after cardiac surgery.(2) Echocardiography is the cornerstone for the diagnosis of septic cardiomyopathy. There is consensus and expert opinion that every hemodynamically unstable patient should receive critical care echocardiography.(3) Improved understanding of sepsis induced myocardial injury is important for multiple reasons. First, cardiac function is crucial for maintaining hemodynamic stability in patients with septic shock. Second, by understanding the clinical features and predictors of sepsis induced myocardial injury, the investigators can discriminate sepsis-induced cardiomyopathy from other cardiac diseases and avoid unnecessary invasive procedures, such as coronary angiography, a risky procedure in critically ill patients. Thus, the investigators aimed to define clinical predictors of sepsis-induced cardiomyopathy and assess the clinical course and outcome of sepsis-induced cardiomyopathy in patients with sepsis.

Подробное описание

Improved understanding of sepsis induced myocardial injury is important for multiple reasons. First, cardiac function is crucial for maintaining hemodynamic stability in patients with septic shock. Second, by understanding the clinical features and predictors of sepsis induced myocardial injury, the investigators can discriminate sepsis-induced cardiomyopathy from other cardiac diseases and avoid unnecessary invasive procedures, such as coronary angiography, a risky procedure in critically ill patients. Thus, the investigators aimed to define clinical predictors of sepsis-induced cardiomyopathy and assess the clinical course and outcome of sepsis-induced cardiomyopathy in patients with sepsis.

Вмешательства

  • Другое observational study
    Predictors and Outcome Of Sepsis Induced Myocardial Injury In Critically Ill Children

Первичные конечные точки

  • Assessment of cardiac function critically ill children with sepsis [Срок оценки: at day 1 of admission and day 5 to 7 after starting treatment]
Вторичные конечные точки (1)
  • Evaluation of permanent cardiac affection post sepsis [Срок оценки: after 3 months (day 90 of admission)]

Критерии участия

Критерии включения

  • Pediatric population aged 1month to 18 years.
  • Critically ill children (who has an illness or injury impairing one or more vital organ systems such that there is high probability of imminent or life-threatening deterioration in the patient's condition)
  • Has clinically and laboratory manifestations of sepsis

Критерии исключения

  • Neonates and adults ( <1 month or >18 years)
  • Children with congenital heart disease
  • Children with Acquired heart disease ( Rheumatic, Myocarditis or Cardiomyopathy)
  • Cardiac surgery

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Египет · 1 центр
  • Assiut University — Asyut

Идентификаторы

NCT: NCT07497139 · Sepsis Myocardial Injury

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗