Navigation Links
Sepsis study comparing 3 treatment methods shows same survival rate
Date:3/18/2014

Survival of patients with septic shock was the same regardless of whether they received treatment based on specific protocols or the usual high-level standard of care, according to a five-year clinical study. The large-scale randomized trial, named ProCESS for Protocolized Care for Early Septic Shock, was done in 31 academic hospital emergency departments across the country and was funded by the National Institute of General Medical Sciences (NIGMS), a component of the National Institutes of Health.

The results of the trial, led by Derek C. Angus, M.D., M.P.H., and Donald M. Yealy, M.D., of the University of Pittsburgh, appear online on March 18, 2014, in the New England Journal of Medicine.

"ProCESS set out to determine whether a specific protocol would increase the survival rates of people with septic shock. What it showed is that regardless of the method used, patient survival was essentially the same in all three treatment groups, indicating that sepsis patients in these clinical settings were receiving effective care," said Sarah Dunsmore, Ph.D., who managed the ProCESS trial for NIGMS.

Sepsis is a body-wide inflammation, usually triggered by an infection. It can lead to a dangerous drop in blood pressure, called septic shock, that starves tissues of oxygen and chokes out major organs: lungs, kidneys, liver, intestines, heart. It remains frustratingly hard to identify, predict, diagnose and treat.

According to the Centers for Disease Control and Prevention, sepsis affects more than 800,000 Americans annually and is the ninth leading cause of disease-related deaths. The Agency for Healthcare Research and Quality lists sepsis as the most expensive condition treated in U.S. hospitals, costing more than $20 billion in 2011.

The ProCESS trial set out to test three approaches to sepsis care. It enrolled 1,341 patients randomly divided into these groups:

Group 1: Early Goal-Directed Therapy

Doctors inserted a central venous cathetera long, thin tube placed close to a patient's heartto continuously monitor blood pressure and blood oxygen levels. For the first six hours of care, doctors kept these levels within tightly specified ranges using intravenous fluids, cardiovascular drugs and blood transfusions. This protocol was based on a 2001 study in an urban emergency department that noted a striking increase in sepsis survival using this approach.

Group 2: Protocolized Standard Care

This alternative tested a less invasive protocol that did not require central venous catheter insertion. Doctors used standard bedside measures like blood pressure (taken using an arm cuff), heart rate and clinical judgment to evaluate patient status and guide treatment decisions. Doctors kept patient blood pressure and fluid levels within specified ranges for the first six hours of care.

Group 3: Standard Care

Patients received the same high level of care they would typically get in an academic hospital emergency department. Their doctors did not follow specific guidelines or protocols associated with the study.

After using an array of statistical analysis tools, the ProCESS investigators concluded that the three treatment arms produced results that were essentially indistinguishable for a range of patient outcomes. These outcomes included survival at 60 days, 90 days and one year; heart and lung function; length of hospital stay; and a standardized measurement of health status at discharge.

"ProCESS helps resolve a long-standing clinical debate about how best to manage sepsis patients, particularly during the critical first few hours of treatment," said Yealy.

"The good news from this study is that, as long as sepsis is recognized promptly and patients are adequately treated with fluid and antibiotics, there is not a mandated need for more invasive care in all patients," added Angus.

In addition to clarifying sepsis treatment options, ProCESS was a milestone for NIGMS.

"ProCESS was the first large-scale clinical trial to be supported by NIGMS, which primarily funds basic, non-disease-targeted research," said Dunsmore. "We hope that ProCESS and other NIGMS- and NIH-funded sepsis research efforts will help improve treatment, speed recovery and increase survival rates for sepsis patients."


'/>"/>

Contact: Alisa Zapp Machalek
alisa.machalek@nih.gov
301-496-7301
NIH/National Institute of General Medical Sciences
Source:Eurekalert

Related medicine news :

1. Special focus issue on sepsis
2. Have researchers found a new treatment for sepsis?
3. BUSM/BMC study shows decrease in sepsis mortality rates
4. Rising rates of severe and fatal sepsis during labor and delivery
5. Four in 10 Adults Have Never Heard of Sepsis, One of the Deadliest Killers in the U.S., New Sepsis Alliance Survey Reveals
6. New discovery permits rapid diagnosis and treatment of sepsis
7. bioMérieux to Feature Sepsis Solutions at New York Meeting of the American Society of Microbiology
8. Breast milk reduces risk of sepsis and intensive care costs in very-low-birth-weight infants
9. Nursing Home Complaint Center Now Makes Public Awareness of Sepsis and Septic Shock in US Nursing Homes Their Number One Initiative for 2013
10. Nursing Home Complaint Center Now Expands Their Initiative Focused On Sepsis Victims In Nursing Homes And Urges Families To Be On The Lookout For Bed Sores
11. Stemedica and Scripps to Jointly Investigate Therapeutic Effect of Ischemia Tolerant Mesenchymal Stem Cells (itMSC) and Stem Cell Factors in Lung Injury and Sepsis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... ... recover from injury. Recently, he has implemented orthobiologic procedures as a method for ... is one of the first doctors to perform the treatment. Orthobiologics are substances ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of ... of the latter, setting the bar too high can result in disappointment, perhaps even ... progress toward their goal. , Research from PsychTests.com reveals that behind ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... To deal with these feelings, many turn to unhealthy avenues, such as drug or ... Center of Marne, Michigan, has released tools for healthy coping following a traumatic event. ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys are recognized ... this recognition are considered among the top 2 percent of lawyers practicing within the ... this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. Bloom, Burt ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Dublin ... of the " Global Markets for Spectroscopy Equipment" ... This report focuses on the global ... including its applications in various applications. The report deals ... three main industries: pharmaceutical and biotechnology, food and beverage, ...
(Date:6/24/2016)... Research and Markets has announced the addition of the ... to their offering. ... World Market for Companion Diagnostics covers the world market for ... report includes the following: , World IVD ... (N. America, EU, ROW), 2015-2020 , World IVD Companion ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced ... as its e-clinical software solution of choice.  This ... best possible value to their clients by offering ... The preferred relationship establishes nowEDC as the EDC ... for MedSource,s full-service clients.  "nowEDC has long been ...
Breaking Medicine Technology: