New Multicenter Study Seeking to Reduce the Devastating Impact of Sepsis Will Rely on Cheetah Medical Inc.'s NICOM(R) Non-Invasive Technology
Published: Feb 13, 2012
TEL-AVIV, Israel and VANCOUVER, Canada, February 13, 2012 /PRNewswire/ --
Cheetah Medical, a leader in non-invasive hemodynamic monitoring announced today the launch of a multicenter clinical study evaluating a novel, aggressive approach for management of sepsis. The study's goal is to reduce progression and morbidity from sepsis. The study, called Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis is being conducted in 12 leading US hospitals.
Sepsis is the body's life-threatening response to infection and leads to shock, multiple organ failure and death, especially if not recognized early and treated promptly. As the primary cause of death from infection, sepsis is responsible for over 200,000 deaths in the US every year, making it the 10th leading cause of death in the nation overall. In fact, one in four hospital deaths are caused by sepsis, where it is the leading cause of death in non-coronary intensive care units (ICUs). It is also rapidly growing in incidence: after adjusting for population size, the annualized incidence of sepsis is increasing by 8%.
Sepsis is a rapidly deteriorating condition where prior research has shown that prompt, aggressive fluid resuscitation which starts shortly after the patient presents to the emergency department is key to reduce mortality from severe sepsis. However, in order to guide fluid management legacy studies utilized highly invasive instrumentation and technology which was available at the time. While effective, the invasive and expensive nature of these protocols has significantly mitigated their adoption in the emergency department setting. In addition, prior studies have focused narrowly at the most severe patients who are far along the disease course, often already in shock and thus are not applicable to the vast majority of septic patients. Research has since shown that up to 25% of the less severe septic patients progress to eventual shock within 72 hours of presentation, resulting in admission to ICU, a host of complications and high risk of death, causing concern amongst many specialists that traditional research has not kept up with clinical need and technology.
The COMMIT study seeks to find an effective, practical and non-invasive solution to guide fluid management that would benefit many more septic patients than the older approaches have allowed.
The Cheetah NICOM is a non-invasive, validated hemodynamic monitoring system which enables emergency medicine physicians and nurses to intervene quickly and effectively with real time guidance on patients' hemodynamic and fluid status. In this study, a treatment protocol based on the NICOM-derived information is compared to the standard practice applied in the participating institutions. Another novelty is the focus on septic patients much earlier in their disease with the goal of preventing progression. In addition to the potential to standardize care and improve sepsis outcomes, if successful, a NICOM-based protocol may bring about significant cost savings to hospitals be preventing complications and usage of invasive instrumentation.
The principal investigator is Dr. Nathan Shapiro, an attending emergency physician at Beth Israel Deaconess Medical Center and an Associate Professor at Harvard Medical School. "We will test whether early and aggressive resuscitation of patients BEFORE the onset of overt shock will prevent downstream organ dysfunction which should curtail subsequent morbidity and mortality," says Dr. Shapiro. "The use of a non-invasive tool to assess cardiac output is a feasible way to monitor a patient in the emergency department and to use physiologic principles to help optimize resuscitation. This is an exciting alternative to the invasive or empiric methods of the past. My co-investigators and I seek to determine whether this theory will translate into clinical practice as an evidenced-based approach to reducing illness in an important population before they overtly deteriorate. "
"Sepsis presents hospitals with staggering challenges, especially in critical care and emergency medicine units. The very high mortality rates from sepsis, the increasing incidence of this disease and the mushrooming costs associated with treating sepsis and its devastating complications speak loud and clear to the fact that existing solutions are inadequate to meet this challenge", said Yoav Avidor, MD, CEO of Cheetah Medical. "NICOM can provide an effective method of optimizing fluid treatment in the emergency department, a vital step in the management of sepsis. We are optimistic that the results of this study will empower clinicians and hospitals to better deal with the clinical and economic aspects of sepsis."
About Cheetah Medical
Cheetah Medical's NICOM® Noninvasive Cardiac Output and Hemodynamic Monitoring System uses the company's proprietary BIOREACTANCE® Technology to deliver continuous, accurate, noninvasive cardiac output (CO) and other vital hemodynamic parameters, useful for fluid management and drug titration. The system is US FDA cleared and CE Marked and since its commercial launch in 2008 has been adopted by hundreds of hospitals worldwide. Cheetah Medical headquarters is located in Tel-Aviv, Israel and its United States headquarters is located in Vancouver, Washington. For more information, visit our website at http://www.cheetah-medical.com.
For further information contact:
Yoav Avidor, MD
SOURCE Cheetah Medical Ltd