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United States : Multi-Center Clinical Study Confirms Decreased Levels of Procalcitonin as an Independent Predictor of Mortality in Patients with Severe Sepsis and Septic Shock.

Thermo Fisher Scientific Inc. today announced that results from the multi-center Procalcitonin MOnitoring SEpsis (MOSES) Study have been published in the May 2017 print issue of Critical Care Medicine. Researchers from the study, titled Serial Procalcitonin Predicts Mortality in Severe Sepsis Patients: Results From the Multicenter Procalcitonin MOnitoring SEpsis (MOSES) Study, investigated the use of the BRAHMS PCT (procalcitonin) assay to assess risk for 28 day all-cause mortality for patients diagnosed with severe sepsis or septic shock in 13 U.S. investigational sites.

Results from the multi-center study showed that patients with a decrease in PCT less than or equal to 80 percent during the first four days following diagnosis of severe sepsis or septic shock had a two-fold increased risk of death as compared to those who experienced a decrease in PCT greater than 80 percent. The study also found that a baseline PCT measurement greater than 2.0 ng/mL is an additional mortality risk factor when evaluating PCT measurements on subsequent days.

Given the significant amount of sepsis-related deaths in the United States, there is a need for a more rigorous and effective approach to monitoring the progression of this syndrome in patients, said lead principal investigator, Nathan I. Shapiro, M.D., MPH, attending physician at the department of emergency medicine at Beth Israel Deaconess Medical Center in Boston. Through the MOSES study, my fellow investigators and I have gained a better understanding of how serial PCT levels can be measured in a hospital setting to further risk-stratify mortality risk.

We are proud to partner with Dr. Nathan Shapiro, Dr. Philipp Schuetz, and all the investigators of the MOSES trial, and support their initiatives in securing publication of this study, said Lonnie Shoff, President of the Clinical Diagnostics Division at Thermo Fisher Scientific. These clinical results further validate and help shed light on the critical role PCT plays in the risk assessment for patients diagnosed with severe sepsis or septic shock. We look forward to continuing the conversation around the importance of sepsis awareness and the impact PCT can have in septic patient management.

As a result of the MOSES study, Thermo Fisher Scientific received expanded FDA clearance for its BRAHMS PCT biomarker assay for sepsis risk assessment. Under the expanded clearance, PCT measurements can be obtained in emergency departments and hospital wards prior to admission to the intensive care unit. Additionally, the clearance helped the Thermo Fisher Scientific license partners, Roche Diagnostics USA and bioMrieux to achieve FDA clearance for the Roche ELECSYS BRAHMS PCT and bioMrieux VIDAS BRAHMS PCT assays in just 90 days, further expanding access to PCT in the United States.

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Publication:Mena Report
Article Type:Clinical report
Date:Apr 22, 2017
Words:451
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