Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ventricular Assist Device with Berlin Heart EXCOR.
- Who it may be relevant to
- Registry conditions: Heart-Assist Devices, Infections, Heart Transplant Infection. Basic parameters: 1 Day — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Relapse of VAD Infections After Discontinuation of Anti-infective Therapies in Children.
Overview
Heart failure is a major cause of mortality and morbidity in children. Heart transplantation can significantly improve the prognosis of patients with severe heart failure, but access is limited by a shortage of transplants. Long-term mechanical circulatory support is a major advance in the management of heart failure and can provide haemodynamic support while awaiting myocardial recovery or heart transplantation. The Berlin Heart (BH) EXCOR is the only long-term support system available for children. Despite technical and medical advances in circulatory support, infection is a common complication and a major cause of morbidity and mortality in patients on BH. There are few studies on the management of infection with mechanical support. Current ISHLT (International Society for Heart and Lung Transplantation) recommendations are based on expert opinion and observational studies. Some experts recommend anti-infective therapy until transplantation for specific support infections or for support-associated infections with persistent bacteraemia.
Interventions
- Device Ventricular Assist Device with Berlin Heart EXCOR
The Berlin Heart® EXCOR is a type of "artificial heart" pump that pulls blood from the ventricle and then sends that blood to the aorta or pulmonary trunc, thereby taking away extra work from the native heart. The device, which comes in several sizes, is not totally implanted inside the body.
Primary outcome measures
- Relapse of VAD-infection after discontinuation of anti-infective therapy [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- patients under 18yo of age with Berlin Heart assisting device in Hospices Civils de Lyon, in France.
Exclusion criteria
- patients over 18 yo at the time of BH assistance
- unavailable documentation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hospices Civils de Lyon — Lyon
Identifiers
NCT: NCT06464016 · AGORA n°23-5221