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

NCT05983341 | Unknown

• 1 other identifier: 69HCL23_0790
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

End-stage heart failure in children is a rare cause of infant mortality. The most frequent cause is dilated cardiomyopathy, often of undetermined origin, which can lead to cardiogenic shock refractory to standard medical treatment. In such cases, it is essential to resort to exceptional means, available at tertiary care hospitals such as in Lyon. The therapeutic means includes long-term circulatory assistance (VAD). This type of circulatory assistance is becoming increasingly used in view of the shortage of heart transplants. Indeed, the average waiting time on the paediatric transplant list varies from 3 months to over a year for children under 5. Berlin Heart EXCOR (BHE) is the only long-term support available for children (2). It is a pulsatile para-corporeal assisting device with percutaneous cannulas. Despite technical and medical advances in circulatory support, the presence of foreign material is frequently complicated by infection. Infection is a major cause of morbidity and mortality in this population. It is most often of nosocomial origin, linked to central line infections. The germs associated with these infections are mainly bacteria, with a small proportion of fungi. The most common pathogens are multi-resistant gram-positive bacteria, which colonize the skin, adhere to the implanted equipment and create biofilms. Infections have a major impact on the morbidity and mortality of patients undergoing mechanical assistance, with an increased risk of thrombo-embolic events and difficulty in managing anticoagulation, secondary to inflammation.

Conditions

Heart Failure; Implant Infection

Keywords

Berlin Heart EXCOR; pediatric; VAD infections; Heart Failure; implanted material infection.

Outcome Measures

Primary Outcomes (1)

• Relapse of infection defined as an infection with an identical from a previous infectious episode germ (microbiological characterization and similar resistance profile).

  Clinical and microbiological diagnosis of a relapse of infection with the same germ after discontinuation of anti-infective therapy in the context of a specific or assistance-related infection

  From time of Berlin Heart EXCOR implantation to up to 6 months after heart transplantation.

Study Arms (1)

Children (<18 years old) with Berlin Heart EXCOR assisting device.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Heart failure pediatric patients in need of ventricular assisting device

You may qualify if:

• Age \< 18years old
• Berlin Heart EXCOR implantation

You may not qualify if:

• None

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mere eEnfant

Bron, Auvergne-Rhône-Alpes, 69500, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: July 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: June 1, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-08

Locations

FR (1)