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

Qualifiers

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 design

Treatments tested in this trial

  • Ventricular Assist Device with Berlin Heart EXCOR

Treatment groups

47 Participants
are divided into 1 treatment group

Sponsors and collaborators

Claude Bernard University

Lead sponsor

Hospices Civils de Lyon

Collaborator