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Идёт набор NCT04604418

Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures

— Наблюдательное Congenital Heart Disease in Children

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: No intervention. It is observational.
Кому может быть актуально
Состояния в реестре: Congenital Heart Disease in Children. Базовые параметры: до 21 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
США, Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The incidence of moderate to severe congenital heart disease (CHD) in the United States is estimated to be 6 per 1000 live-born full term infants. Recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with CHD leading to an increase in prevalence in both children and adults. Children with CHD significant enough to require cardiac surgery frequently also undergo non-cardiac surgical procedures. Analysis of the Pediatric Health Information System database between 2004 and 2012 demonstrated that 41% of children who had undergone surgery to correct CHD in the first year of life also underwent at least one non-cardiac surgery by age 5. With this increased demand for non-cardiac procedures, anesthesiologists, pediatricians and other healthcare providers will encounter patients with repaired or unrepaired CHD and other cardiac diseases in their practice. However, the information provided by national databases lack granularity and the information from single institutional data is limited. This project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. To conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. The aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts.

Вмешательства

  • Другое No intervention. It is observational
    No intervention. It is observational

Первичные конечные точки

  • Mortality [Срок оценки: during the procedure and up to 30-days following the procedure]
  • Intensive Care Unit admission [Срок оценки: following the procedure and up to 72 hours]
  • Postoperative mechanical support [Срок оценки: following the procedure and up to 72 hours]
  • Intraoperative cardiac event [Срок оценки: During the perioperative period]
Вторичные конечные точки (4)
  • Readmission Cardiac arrest: during the procedure and up to 72 hours Neurologic injury (stroke, seizure) following the procedure and up to 72 hours Renal injury following the procedure and up to 72 hours [Срок оценки: following the procedure and up to 72 hours]
  • Cardiac arrest [Срок оценки: during the procedure and up to 72 hours]
  • Neurologic injury [Срок оценки: Following the procedure and up to 72 hours]
  • Renal Injury [Срок оценки: Following the procedure and up to 72 hours]

Критерии участия

Критерии включения

  • Males or females ages birth to 21 years.
  • Patients diagnosed with congenital heart disease
  • Patients undergoing a noncardiac procedure (surgical or nonsurgical)

Критерии исключения

  • Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.
  • Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 9 центров
  • University of California, Los Angeles — Los Angeles
  • Children's National Medical Center — Washington D.C.
  • Children's Healthcare of Atlanta - Egleston Hospita — Atlanta
  • Boston Children's Hospital — Boston
  • University of Minnesota Medical Center — Minneapolis
  • Children's Hospital of Philadelphia — Philadelphia
  • Vanderbilt University Medical Center — Nashville
  • Texas Children's Hospital — Houston
  • … и ещё 1 центр
Канада · 1 центр
  • Hospital for Sick Kids — Toronto

Идентификаторы

NCT: NCT04604418 · IRB-P00035008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗