Resuscitation Registry in CHD

Cardiac Arrest Clinical Trial

— PRO-CHD  

Official title:

Pediatric Resuscitation Outcome in Children With Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05373498
• Other study ID #: 2020-0450
• Status: Recruiting
• Start date: August 18, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: March 2023
• Source: Leipzig Heart Science gGmbH
• Contact: Franziska Markel, Dr. med.
• Phone: +49341865253025
• Email: Franziska.Wagner[@]helios-gesundheit.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2032
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Arrest
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Herzzentrum Leipzig	Leipzig	Sachsen

Sponsors (5)

Lead Sponsor	Collaborator
Leipzig Heart Science gGmbH	Deutsche Gesellschaft für Pädiatrische Kardiologie und Angeborene Herzfehler e.V., Heart Center Leipzig - University Hospital, Stiftung KinderHerz, Zentrum für Klinische Studien Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival to hospital discharge		until the date of discharge or death from any cause, whichever came first, assessed up to 2 months
Secondary	Number of return of spontaneous circulation		until the date of discharge or spontaneous circulation from any cause, whichever came first, assessed up to 2 months
Secondary	Rate of morbidity		until 2 years