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NCT Number: NCT05373498

Resuscitation Registry in CHD

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Arrest Heart Defects, Congenital Heart Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Herzzentrum Leipzig, Leipzig, Saxony, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Rate of morbidity

    Time frame: until 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Franziska Markel, Dr. med.

CONTACT

[email protected]

+49341865253025

Sponsors and collaborators

Lead sponsor

Leipzig Heart Science gGmbH

Other

Collaborators

  • Deutsche Gesellschaft für Pädiatrische Kardiologie und Angeborene Herzfehler e.V.
  • Heart Center Leipzig - University Hospital
  • Stiftung KinderHerz
  • Zentrum für Klinische Studien Leipzig

Registry information

Official study title

Pediatric Resuscitation Outcome in Children With Heart Disease

Acronym: PRO-CHD

Important dates

Study start
2022
Primary completion
2030
Study completion
2032
First posted
May 13, 2022
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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