Ignite Creation Date:
2024-05-06 @ 12:02 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01471795
Status:
COMPLETED
Last Update Posted:
2011-11-16
First Post:
2011-11-07
Brief Title:
The Epidemiology of Ventricular Assist Device-Related Infections
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
The Epidemiology of Ventricular Assist Device-Related Infections
Status:
COMPLETED
Status Verified Date:
2011-11
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:
None
Brief Summary:
Infections often occur after ventricular assist devices VADs are placed These infections can be very serious The goal of this study is to understand why these infections occur Bacteria germs normally live on our skin and in our noses After surgery they can infect the VAD The investigators will collect cultures of your skin and nose before and after surgery The investigators will compare these bacteria to bacteria that cause infections Their genes will be compared to see which ones help the bacteria cause infection
Detailed Description:
Infections are one of the most serious of ventricular assist device VAD related complications Many of these infections are associated with significant patient morbidity and mortality Diagnosis of these infections is often difficult due to the complicated nature of the patients medical problems the need for rapid institution of empiric antibiotic therapy and the lack of established criteria that define infection Staphylococci are among the most common causes of VAD infections The basis for this high incidence is not well understood but is believed to be in part due to inoculation of staphylococcal commensal flora into wound sites at the time of surgery or thereafter The goals of this observational study are to develop a better understanding of the pathogenesis and epidemiology of Staphylococcus aureus and epidermidis-VAD infections as well as to develop a set of criteria that can be used to help diagnose the presence or absence of a VAD related infection
This is a prospective multi-center observational study to identify risk factors associated with the development of VAD-related infections Patients will be followed for up to one year following VAD implantation time of death or transplantation whichever comes first There will be no randomization for this observational study
This is a prospective multi-center observational study to identify risk factors associated with the development of VAD-related infections Patients will be followed for up to one year following VAD implantation time of death or transplantation whichever comes first There will be no randomization for this observational study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P50HL077096 | NIH | None | httpsreporternihgovquickSearch5P50HL077096 |