Resuscitation Registry in CHD

Overview

Children with congenital heart defects are far more likely to suffer a cardiovascular arrest and be in the need of cardiopulmonary resuscitation than healthy children or those with diseases of other organ systems, especially after cardiothoracic surgery. Due to a lack of data, the exact number of resuscitations in this patient cohort, as well as the morbidity and mortality, is unknown. This study aims to register all cardiovascular arrests in pediatric patients with congenital heart disease and study the mortality and morbidity with a special focus on the neurodevelopmental outcome.

Full Title of Study: “Pediatric Resuscitation Outcome in Children With Heart Disease”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 31, 2024

Detailed Description

Background and aim: Children with heart defects, especially those after heart surgery, have an up to ten times higher risk for an in-hospital cardiac arrest, compared to children without heart disease. Although this patient cohort is particularly vulnerable, these events and outcomes are not systematically monitored in Germany. We designed a prospective multicenter-registry study aiming to record in-hospital cardiac arrests of children with congenital- (CHD) and acquired heart disease in Germany. Methods: A web-based registry was designed, prospectively collecting data (patient´s demographics, CPR data, post-resuscitation care and clinical course, neurological outcome and follow-up), according to the Utstein template. All children (0-18 years) with heart disease suffering a cardiac arrest requiring resuscitation of ≥ two minutes will be included. The primary outcome is survival to discharge, the secondary outcome is morbidity, with a particular focus on neurological morbidity. An inclusion of 10-20 children/centre/year is anticipated. As this is an observational study, no intervention is planned. Results: This registry will provide data on the mortality, early and mid-term neurologic outcome, and quality of life after cardiac arrest of children with heart disease in Germany. Correlations between patients´ characteristics, resuscitation characteristics and post-resuscitation care with primary and secondary outcomes will be analyzed. Conclusions: By systematically recording and analyzing the outcome after in-hospital cardiac arrest in children with CHD, this study is an important first step to close knowledge gaps regarding the risk factors and outcome of cardiac arrest in this patient group, and aims to improve care and outcomes of these vulnerable patients.

Clinical Trial Outcome Measures

Primary Measures

  • survival to hospital discharge
    • Time Frame: until the date of discharge or death from any cause, whichever came first, assessed up to 2 months

Secondary Measures

  • Number of return of spontaneous circulation
    • Time Frame: until the date of discharge or spontaneous circulation from any cause, whichever came first, assessed up to 2 months
  • Rate of morbidity
    • Time Frame: until 2 years

Participating in This Clinical Trial

Inclusion Criteria

  • congenital heart defects, congenital heart arrhythmia, familial cardiomyopathies, inflammatory heart diseases – pediatric resuscitation (chest compressions ≥2min) in hospital or on arrival in hospital – age <18 years – informed consent of the parents or legal representative Exclusion Criteria:

  • absence or withdrawal of informed consent of the parents or legal representative – do-not-resuscitate-order (DNR)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Leipzig Heart Science gGmbH
  • Collaborator
    • Heart Center Leipzig – University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Franziska Markel, Dr. med., +49341865253025, Franziska.Wagner@helios-gesundheit.de

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