The Epidemiology of Ventricular Assist Device-Related Infections
15 de noviembre de 2011 actualizado por: Icahn School of Medicine at Mount Sinai
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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 patient's 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.
Tipo de estudio
De observación
Inscripción (Actual)
150
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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California
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San Diego, California, Estados Unidos, 92123
- Sharp Memorial Hospital
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Illinois
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Oak Lawn, Illinois, Estados Unidos, 60453
- Advocate Christ Medical Center
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Jewish Hospital
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota
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New York
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Bronx, New York, Estados Unidos, 10467
- Montefiore Medical Center
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New York, New York, Estados Unidos, 10032
- Columbia Presbyterian Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Hospital of the University of Pennsylvania
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Utah
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Salt Lake City, Utah, Estados Unidos, 84143
- LDS Hospital
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Washington
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Spokane, Washington, Estados Unidos, 99204
- Sacred Heart Medical Center
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin Hospital
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Milwaukee, Wisconsin, Estados Unidos, 53215
- St. Luke's Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Patients with end-stage heart failure who demonstrate the need for intermediate or long-term support with a VAD.
Descripción
Inclusion Criteria:
- Age greater than or equal to 18 years.
- Approved by the institution's heart failure/transplant committee for VAD implantation, either as a bridge to cardiac transplantation or for destination therapy for end-stage heart failure.
- Signed informed consent, release of medical information, and HIPAA forms.
- Expectation of compliance with protocol procedures and study visit schedule.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Study Population
150 subjects with end-stage heart failure who have been scheduled to undergo device implantation with a VAD, either as a bridge to cardiac transplantation or for destination therapy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The incidence of suspected infections, characterized by infecting organism and location.
Periodo de tiempo: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
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The primary goal is to collect information that describes infections in patients receiving LVADs.
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Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Collect and quantify culture results for suspected infections and the secondary manifestations of infection
Periodo de tiempo: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
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Bacteria normally live on our skin and in our noses.After surgery, they can infect the VAD.
We will collect cultures before and after surgery and compare these bacteria to bacteria that cause infections.Their genes will be compared to see which ones help the bacteria cause infection.
We hope this will help develop new ways to help prevent VAD infections.
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Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
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Develop Guidelines to properly diagnose VAD infections
Periodo de tiempo: Up to one year following VAD implantation, time of death or transplantation, whichever comes first.
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Information will be collected on patient's medical condition after surgery including blood tests to help determine if an infection is present.
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Up to one year following VAD implantation, time of death or transplantation, whichever comes first.
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Costs (direct)
Periodo de tiempo: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
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The value of all resources that are consumed in the provision of an intervention or dealing with the side-effects or other current and future consequences linked to it.
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Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
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Adverse Events
Periodo de tiempo: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
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Since this is an observational study there will be no adverse events directly attributable to a study intervention.
However, adverse events that might potentially contribute to the risk or course of VAD-related infections will be monitored.
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Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michael Parides, PhD, Icahn School of Medicine at Mount Sinai
- Director de estudio: Patrice Desvigne-Nickens, National Heart, Lung, and Blood Institute (NHLBI)
- Silla de estudio: Yoshifumi Naka, MD, Columbia University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Gordon RJ, Weinberg AD, Pagani FD, Slaughter MS, Pappas PS, Naka Y, Goldstein DJ, Dembitsky WP, Giacalone JC, Ferrante J, Ascheim DD, Moskowitz AJ, Rose EA, Gelijns AC, Lowy FD; Ventricular Assist Device Infection Study Group. Prospective, multicenter study of ventricular assist device infections. Circulation. 2013 Feb 12;127(6):691-702. doi: 10.1161/CIRCULATIONAHA.112.128132. Epub 2013 Jan 11.
- Gordon RJ, Miragaia M, Weinberg AD, Lee CJ, Rolo J, Giacalone JC, Slaughter MS, Pappas P, Naka Y, Tector AJ, de Lencastre H, Lowy FD. Staphylococcus epidermidis colonization is highly clonal across US cardiac centers. J Infect Dis. 2012 May 1;205(9):1391-8. doi: 10.1093/infdis/jis218. Epub 2012 Mar 29.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2006
Finalización primaria (Actual)
1 de enero de 2009
Finalización del estudio (Actual)
1 de enero de 2009
Fechas de registro del estudio
Enviado por primera vez
7 de noviembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
15 de noviembre de 2011
Publicado por primera vez (Estimar)
16 de noviembre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de noviembre de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
15 de noviembre de 2011
Última verificación
1 de noviembre de 2011
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 08-1093 HP
- 5P50HL077096 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .