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The purpose of this study is to determine whether the Seraph® Microbind® Affinity Blood Filter is safe in the treatment of dialysis patients with bacteremia from Staphylococcus aureus.
This trial is a prospective, non-randomized study in patients as an adjunctive treatment for blood stream infection (BSI) in patients on renal replacement therapy The heparin surface being studied is currently marketed on extracorporeal circuits. It has been shown to absorb various types of Gram positive and Gram negative bacteria including Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA) and to reduce toxins and cytokines in in vitro studies using whole blood. For this study, patients on renal replacement therapy who develop bacteremia will have the Seraph® Microbind® Affinity Blood Filter included in the dialysis circuit for up to 4 hours, on one day, with hourly monitoring. Patients will be followed for 14 days post treatment. Patients will be monitored by vital signs and laboratory indices on the day of treatment and on post procedure day 1, 7 and 14.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Seraph Microbind Affinity Blood Filter
ExThera Medical Corporation
Published on BioPortfolio: 2016-09-26T22:23:21-0400
To assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Bacteremia Assay.
The Oxiris® filter is a registered product for CRRT already safely used in routine care. In in vitro experiments, the Oxiris® filter has been demonstrated to adsorb endotoxin and cytoki...
This study was designed to assess the safety of retrieval of the Bard Recovery® G2® Filter System. The G2 filter is an FDA-cleared device for inferior vena caval interruption in patients...
The presence of bacteremia and sepsis in percent of critically ill patients and none at all, associated with different expression and faction of Toll-Like-Receptors (TLRs.
The study is a blinded cross over test of in-home air filtration. Participants will have a window unit air filter (HEPA) installed that will filter for 3 weeks and do sham filtration for a...
Bloodstream infections remain a major cause of morbidity and mortality. Gram-negative bacilli (GNB) bacteremia is typically transient and usually resolves rapidly after the initiation of appropriate a...
We explored the use of filter paper soaked in whole blood for measuring carbon (C) and nitrogen (N) stable isotopes, often used in feeding ecology or diet studies, to better understand drivers of ...
Streptococcus agalactiae or group B streptococcus (GBS) is a frequent pathogen in immunocompromised adults. The aim of this study was to determine the relative frequency, clinical presentation, antimi...
For febrile children who are evaluated in a pediatric emergency department (PED), blood culture can be considered the laboratory criterion standard to detect bacteremia. However, high rates of negativ...
The global antimicrobial resistance surveillance system (GLASS) was launched by the World Health Organization (WHO) in 2015. GLASS is a surveillance system for clinical specimens that are sent to micr...
The presence of viable bacteria circulating in the blood. Fever, chills, tachycardia, and tachypnea are common acute manifestations of bacteremia. The majority of cases are seen in already hospitalized patients, most of whom have underlying diseases or procedures which render their bloodstreams susceptible to invasion.
Techniques for using whole blood samples collected on filter paper for a variety of clinical laboratory tests.
Test to determine the presence of blood infection (e.g. SEPSIS; BACTEREMIA).
Specialized phagocytic cells of the MONONUCLEAR PHAGOCYTE SYSTEM found on the luminal surface of the hepatic sinusoids. They filter bacteria and small foreign proteins out of the blood, and dispose of worn out red blood cells.
Infectious organisms in the BLOOD, of which the predominant medical interest is their contamination of blood-soiled linens, towels, gowns, BANDAGES, other items from individuals in risk categories, NEEDLES and other sharp objects, MEDICAL WASTE and DENTAL WASTE, all of which health workers are exposed to. This concept is differentiated from the clinical conditions of BACTEREMIA; VIREMIA; and FUNGEMIA where the organism is present in the blood of a patient as the result of a natural infectious process.
Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...
Chronic kidney disease (CKD), also known as chronic renal disease, is a progressive loss in renal function over a period of months or years. The symptoms of worsening kidney function are non-specific, and might include feeling generally unwell and experi...