Actively Recruiting

Age: 1Day - 18Years
All Genders
NCT06464016

Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.

Led by Claude Bernard University · Updated on 2025-01-28

47

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

Sponsors

C

Claude Bernard University

Lead Sponsor

H

Hospices Civils de Lyon

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.

Who Can Participate

Age: 1Day - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is under 18 years old
  • Currently using a Berlin Heart assisting device at Hospices Civils de Lyon, France
Not Eligible

You will not qualify if you...

  • Patient is 18 years old or older at the time of Berlin Heart assistance
  • Medical documentation is unavailable

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospices Civils de Lyon

Lyon, France, 69677

Actively Recruiting

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Research Team

C

Charlotte Leclercq, MD PhD

CONTACT

M

Marc Lilot, MCU

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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