Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorClaude Bernard University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients under 18yo of age with Berlin Heart assisting device in Hospices Civils de Lyon, in France.
Disqualifiers
patients over 18 yo at the time of BH assistance
unavailable documentation
Trial population
Children with terminal heart failure receiving BH assistance as bridge to transplant or bridge to recovery.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Ventricular Assist Device with Berlin Heart EXCOR
DeviceThe 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.
Treatment groups
47 Participants
are divided into 1 treatment groupGroup A: Pediatric patients with Berlin Heart EXCOR1 intervention
Trial outcomes
Primary outcomes
1
Relapse of VAD-infection after discontinuation of anti-infective therapy
Clinical and microbiological diagnosis of recurrence of infection with the same pathogen within 3 months of cessation of anti-infective therapy for a VAD-specific or VAD-related infection.
Time frame
3 monthsSponsors and contacts
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Claude Bernard University
Lead sponsor
Hospices Civils de Lyon
Collaborator
Source ClinicalTrials.gov