The Epidemiology of Ventricular Assist Device-Related Infections
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|ClinicalTrials.gov Identifier: NCT01471795|
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : November 16, 2011
|Condition or disease|
|Congestive Heart Failure|
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.
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||The Epidemiology of Ventricular Assist Device-Related Infections|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
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.
- The incidence of suspected infections, characterized by infecting organism and location. [ Time Frame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first. ]The primary goal is to collect information that describes infections in patients receiving LVADs.
- Collect and quantify culture results for suspected infections and the secondary manifestations of infection [ Time Frame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first. ]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.
- Develop Guidelines to properly diagnose VAD infections [ Time Frame: Up to one year following VAD implantation, time of death or transplantation, whichever comes first. ]Information will be collected on patient's medical condition after surgery including blood tests to help determine if an infection is present.
- Costs (direct) [ Time Frame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first. ]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.
- Adverse Events [ Time Frame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471795
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Sharp Memorial Hospital|
|San Diego, California, United States, 92123|
|United States, Illinois|
|Advocate Christ Medical Center|
|Oak Lawn, Illinois, United States, 60453|
|United States, Kentucky|
|Louisville, Kentucky, United States, 40202|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Columbia Presbyterian Medical Center|
|New York, New York, United States, 10032|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Utah|
|Salt Lake City, Utah, United States, 84143|
|United States, Washington|
|Sacred Heart Medical Center|
|Spokane, Washington, United States, 99204|
|United States, Wisconsin|
|University of Wisconsin Hospital|
|Madison, Wisconsin, United States, 53792|
|St. Luke's Medical Center|
|Milwaukee, Wisconsin, United States, 53215|
|Study Director:||Patrice Desvigne-Nickens||National Heart, Lung, and Blood Institute (NHLBI)|
|Study Chair:||Yoshifumi Naka, MD||Columbia University|
|Principal Investigator:||Michael Parides, PhD||Icahn School of Medicine at Mount Sinai|