Resuscitation Registry in CHD

NCT05373498 | Recruiting

• 1 other identifier: 2020-0450
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cardiac Arrest; Congenital Heart Disease

Keywords

pediatric resuscitation outcome; congenital heart disease; neurodevelopmental outcome

Outcome Measures

Primary Outcomes (1)

• survival to hospital discharge

  until the date of discharge or death from any cause, whichever came first, assessed up to 2 months

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children: 0 - 18 years

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (3)

Herzzentrum Leipzig

Leipzig, Saxony, 04289, Germany

RECRUITING

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

NOT YET RECRUITING

Universitätsklinikum Bonn (AöR)

Bonn, 53127, Germany

NOT YET RECRUITING

Related Publications (1)

• Markel F, Kramer P, Anand J, Heimberg E, Herbsleb V, Amann V, Herberg U, von Borell du Vernay F, Seidemann K, Liem L, Michaelis A, Schmitt K, Weidenbach M. Paediatric Resuscitation Outcome in Children with Heart Disease (ProCHD): protocol of a Germany-wide multicentre, prospective open registry. BMJ Open. 2026 Jan 8;16(1):e107163. doi: 10.1136/bmjopen-2025-107163.

  PMID: 41506771 DERIVED

MeSH Terms

Conditions

Heart Arrest; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Franziska Markel, Dr. med.

CONTACT

+49341865253025; Franziska.Markel@helios-gesundheit.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: May 13, 2022
• Study Start: August 18, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

DE (3)