Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:


Sepsis study comparing 3 treatment methods shows same survival rate


NIH-funded clinical trial tested specific protocols against usual high-level care

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.

... more about:
»Health »NIGMS »NIH »Sepsis »blood »septic »shock

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 catheter—a long, thin tube placed close to a patient's heart—to 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."


Research reported in this release was supported by the National Institute of General Medical Sciences of the National Institutes of Health under grant number P50 GM076659. For more information about clinical trial NCT00510835, visit

To arrange an interview with NIGMS program director Sarah Dunsmore, Ph.D., contact the NIGMS Office of Communications and Public Liaison at 301-496-7301 or

For more information about sepsis, see the fact sheet at .

NIGMS is a part of NIH that supports basic research to increase our understanding of life processes and lay the foundation for advances in disease diagnosis, treatment and prevention. For more information on the Institute's research and training programs, see

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit

NIH…Turning Discovery Into Health®

Alisa Zapp Machalek | EurekAlert!

Further reports about: Health NIGMS NIH Sepsis blood septic shock

More articles from Health and Medicine:

nachricht UofL scientists identify critical pathway to improve muscle repair
01.12.2015 | University of Louisville

nachricht University of California Scientists Create Malaria-Blocking Mosquitoes
30.11.2015 | University of California, Irvine

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: How do Landslides control the weathering of rocks?

Chemical weathering in mountains depends on the process of erosion.

Chemical weathering of rocks over geological time scales is an important control on the stability of the climate. This weathering is, in turn, highly dependent...

Im Focus: How Cells in the Developing Ear ‘Practice’ Hearing

Before the fluid of the middle ear drains and sound waves penetrate for the first time, the inner ear cells of newborn rodents practice for their big debut. Researchers at Johns Hopkins report they have figured out the molecular chain of events that enables the cells to make “sounds” on their own, essentially “practicing” their ability to process sounds in the world around them.

The researchers, who describe their experiments in the Dec. 3 edition of the journal Cell, show how hair cells in the inner ear can be activated in the absence...

Im Focus: Climate study finds evidence of global shift in the 1980s

Planet Earth experienced a global climate shift in the late 1980s on an unprecedented scale, fuelled by anthropogenic warming and a volcanic eruption, according to new research published this week.

Scientists say that a major step change, or ‘regime shift’, in the Earth’s biophysical systems, from the upper atmosphere to the depths of the ocean and from...

Im Focus: Innovative Photovoltaics – from the Lab to the Façade

Fraunhofer ISE Demonstrates New Cell and Module Technologies on its Outer Building Façade

The Fraunhofer Institute for Solar Energy Systems ISE has installed 70 photovoltaic modules on the outer façade of one of its lab buildings. The modules were...

Im Focus: Lactate for Brain Energy

Nerve cells cover their high energy demand with glucose and lactate. Scientists of the University of Zurich now provide new support for this. They show for the first time in the intact mouse brain evidence for an exchange of lactate between different brain cells. With this study they were able to confirm a 20-year old hypothesis.

In comparison to other organs, the human brain has the highest energy requirements. The supply of energy for nerve cells and the particular role of lactic acid...

All Focus news of the innovation-report >>>



Event News

European Geosciences Union meeting: Media registration now open (EGU 2016 media advisory 1)

01.12.2015 | Event News

Urbanisation and migration from rural areas challenging agriculture in Eastern Europe

30.11.2015 | Event News

Fraunhofer’s Urban Futures Conference: 2 days in the city of the future

25.11.2015 | Event News

Latest News

Tracing a path toward neuronal cell death

01.12.2015 | Life Sciences

Researchers grow retinal nerve cells in the lab

01.12.2015 | Life Sciences

Lazy microbes are key for soil carbon and nitrogen sequestration

01.12.2015 | Earth Sciences

More VideoLinks >>>