Cardiac ArrestPRO-CHDNCT05373498
Resuscitation Registry in CHD
An observational study of Cardiac Arrest and Congenital Heart Disease, run by Leipzig Heart Science gGmbH at 3 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiac Arrest, Congenital Heart Disease
- How many people
- 400 participants
- Where
- 3 sitesGermany
- Study dates
- 18 Aug 2022to 31 Dec 2032
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children: 0 - 18 years
Who may be able to join
- 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
Who cannot join
- absence or withdrawal of informed consent of the parents or legal representative
- do-not-resuscitate-order (DNR)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Not yet recruiting
Deutsches Herzzentrum Berlin
Berlin, 13353
Katharina Schmitt, Prof. Dr. med.
Peter Kramer, Dr. med.
- Not yet recruiting
Universitätsklinikum Bonn (AöR)
Bonn, 53127
Valérie Amann, Dr.
- Recruiting
Herzzentrum Leipzig
Leipzig, Saxony, 04289
Franziska Markel, Dr. med.
Michael Weidenbach, PD Dr. med.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Arrest, Congenital Heart Disease
- Keywords
- pediatric resuscitation outcome, congenital heart disease, neurodevelopmental outcome
- Medical subject headings
- Heart Arrest, Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
survival to hospital discharge
Measured: 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
Measured: until the date of discharge or spontaneous circulation from any cause, whichever came first, assessed up to 2 months
Rate of morbidity
Measured: until 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start18 Aug 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Leipzig Heart Science gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital, Zentrum für Klinische Studien Leipzig, Deutsche Gesellschaft für Pädiatrische Kardiologie und Angeborene Herzfehler e.V., Stiftung KinderHerz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373498
- Sponsor's protocol ID
- 2020-0450
- Acronym
- PRO-CHD
- Status last verified
- Jan 2025
- First submitted
- 25 Mar 2022
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41506771
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Resuscitation Outcome in Children With Heart Disease
- ClinicalTrials.gov ID
- NCT05373498
- Acronym / sponsor ID
- PRO-CHD / 2020-0450
- Conditions
- Cardiac Arrest, Congenital Heart Disease
- Keywords
- pediatric resuscitation outcome, congenital heart disease, neurodevelopmental outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Leipzig Heart Science gGmbHUniversity, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital, Zentrum für Klinische Studien Leipzig, Deutsche Gesellschaft für Pädiatrische Kardiologie und Angeborene Herzfehler e.V., Stiftung KinderHerz
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children: 0 - 18 years
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- absence or withdrawal of informed consent of the parents or legal representative
- do-not-resuscitate-order (DNR)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
survival to hospital discharge
Time frame: until the date of discharge or death from any cause, whichever came first, assessed up to 2 months
2 secondary outcomes
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
Rate of morbidity
Time frame: until 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Derived from this study: PubMed 41506771Markel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Congenital Heart Disease, run by Leipzig Heart Science gGmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franziska Markel, Dr. med. (+49341865253025, Franziska.Markel@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival to hospital discharge (time frame: until the date of discharge or death from any cause, whichever came first, assessed up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05373498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.