Registry of cardiac arrests in children with congenital heart disease
Pediatric Resuscitation Outcome in Children With Heart Disease
This study is collecting information on cardiac arrests in children with congenital heart disease in Germany to see how these events affect their recovery and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Leipzig Heart Science gGmbH Academic / other |
| Locations | 3 sites (Leipzig, Saxony and 2 other locations) |
| Trial ID | NCT05373498 on ClinicalTrials.gov |
What this trial studies
This observational study aims to systematically record in-hospital cardiac arrests in pediatric patients with congenital heart disease in Germany. It will collect data on patient demographics, resuscitation efforts, post-resuscitation care, and neurological outcomes using a web-based registry. The study focuses on understanding the mortality and morbidity associated with cardiac arrests in this vulnerable population, particularly after heart surgery. By analyzing correlations between patient characteristics and outcomes, the study seeks to provide valuable insights into the care of these children.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old with congenital heart defects or related conditions who experience a cardiac arrest requiring resuscitation.
Not a fit: Patients who have a do-not-resuscitate order or for whom informed consent cannot be obtained will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of outcomes after cardiac arrest in children with congenital heart disease, potentially leading to better care practices.
How similar studies have performed: While there is limited systematic data on this specific cohort, similar observational studies have shown success in improving outcomes through better data collection and analysis.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Leipzig, Saxony and 2 other locations
- Herzzentrum Leipzig — Leipzig, Saxony, Germany (Recruiting)
- Deutsches Herzzentrum Berlin — Berlin, Germany (Not_yet_recruiting)
- Universitätsklinikum Bonn (AöR) — Bonn, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Franziska Markel, Dr. med.
- Email: Franziska.Markel@helios-gesundheit.de
- Phone: +49341865253025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.