Resuscitation Registry in CHD (PRO-CHD)

Pediatric Resuscitation Outcome in Children With Heart Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest; Congenital Heart Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Franziska Markel, Dr. med.; Phone Number: +49341865253025; Email: Franziska.Markel@helios-gesundheit.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Not yet recruiting
    • Deutsches Herzzentrum Berlin
    • Contact: Katharina Schmitt, Prof. Dr. med.
    • Contact: Peter Kramer, Dr. med.
  • Bonn, Germany, 53127
    • Not yet recruiting
    • Universitätsklinikum Bonn (AöR)
    • Contact: Valérie Amann, Dr.
  • Sachsen
    • Leipzig, Sachsen, Germany, 04289
      • Recruiting
      • Herzzentrum Leipzig
      • Contact: Franziska Markel, Dr. med.
      • Contact: Michael Weidenbach, PD Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children: 0 - 18 years

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Rate of morbidity	until 2 years

Collaborators and Investigators

• Sponsor: Leipzig Heart Science gGmbH
• Collaborators: Heart Center Leipzig - University Hospital; Zentrum für Klinische Studien Leipzig; Deutsche Gesellschaft für Pädiatrische Kardiologie und Angeborene Herzfehler e.V.; Stiftung KinderHerz

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: congenital heart disease; neurodevelopmental outcome; pediatric resuscitation outcome
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 2020-0450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No