Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464016
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-10-10
Brief Title:
Complications in Pediatric Mechanical Circulatory Assistance Evaluation of Infection Management
Sponsor:
Claude Bernard University
Organization:
Claude Bernard University
Study Overview
Official Title:
Relapse of VAD Infections After Discontinuation of Anti-infective Therapies in Children
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VADINFECT
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None