News Release

Monday, October 2, 2006

New Study Aims to Stop Sepsis in its Tracks

If you’ve had a heart attack or stroke, paramedics, doctors, and
nurses follow standardized protocols for what to do right away,
and their efforts improve your odds for a full recovery. That’s
not the case if you have a body-wide infection known as sepsis,
which can be fatal within a few hours and is often not diagnosed
until it is too late.

Now, a new, multicenter research consortium, called Protocolized
Care for Early Septic Shock (ProCESS), is beginning a large-scale
study to determine whether specific interventions can halt the
progression to severe sepsis and septic shock. Key to the project
is determining whether there are “golden hours” during which prompt,
rigorous, standardized care can save patients’ lives.

The project may establish the first set of standard procedures
to diagnose and treat sepsis in emergency departments.

The National Institute of General Medical Sciences (NIGMS), part
of the National Institutes of Health, launched the project this
month with a grant totaling more than $8.4 million over five years.
Derek C. Angus, M.D., M.P.H.of the University of Pittsburgh School
of Medicine, leads the consortium, which is a partnership between
physicians in emergency medicine and those in critical care medicine.

“By improving the treatment of those critically ill with sepsis,
the consortium’s work will have enormous implications for the thousands
of patients who suffer from this infection,” said NIH Director
Elias A. Zerhouni, M.D.

Every year, sepsis affects more than 700,000 Americans. About
30 percent of them die. Sepsis occurs when the body's normal reaction
to an infection goes into overdrive, causing widespread inflammation
and dramatic changes in body temperature, blood pressure, breathing,
and heart rate. It can lead to the malfunction or failure of several
major organs.

“The goal of this project is to speed recovery, increase survival
rates, and improve the long-term quality of life for those who
have had sepsis,” said NIGMS Director Jeremy M. Berg, Ph.D.

One of the major challenges is to recognize sepsis when it starts.
That’s because in its early stages, it is often mistaken for a
milder infection or other problems, said Angus. "A person may arrive
with what looks like a simple case of pneumonia, and the emergency
department team starts antibiotics and believes things will go
well. Only when the blood pressure drops or is no longer responsive
to intravenous fluids does the team realize it is suddenly behind
the eight ball. By then, the patient is quickly spiraling into
multisystem organ failure. Starting resuscitation at this point
may already be too late."

To test ways of managing the disease during the first six hours
after diagnosis, the consortium will train teams of doctors, nurses,
and other emergency department workers at more than a dozen institutions.
Like dedicated trauma teams, the sepsis teams will focus all their
attention on one patient at a time and will follow a scripted protocol
to stabilize, diagnose, and treat sepsis.

The protocol includes a sequence of resuscitation methods to deliver
fluids, restore blood pressure, and monitor cardiovascular function
and other organ activity. It was developed several years ago by
Emanuel Rivers, M.D., M.P.H., a researcher and physician at Henry
Ford Hospital in Detroit, where it dramatically increased survival
rates.

To implement this approach across the entire country is a daunting
task. As a first step, the consortium aims to find out whether
the protocol will have similar success at multiple hospitals across
the nation.

Following a year-long period of establishing and training sepsis
teams, the consortium plans to treat early severe sepsis in nearly
2,000 patients, enrolling patients over a two- to three-year period.
It will randomly assign patients to Rivers’ protocol or to the
existing “usual care” approach, which does not include such aggressive
resuscitation. It will then follow all the patients for a full
year after their recovery to detect any long-term differences in
health and mortality rates.

The scientists will also measure blood levels of certain factors
that are thought to cause severe sepsis. By examining how these
levels change over time and with the different interventions, the
scientists will discover whether the factors can serve as molecular
markers to help track organ function and recovery progress in patients.
This molecular approach may also shed light on new ways to understand
and treat sepsis.

And consortium researchers will study the cost-effectiveness and
logistics of establishing such protocols in emergency departments
around the country. The scientists aim to develop a blueprint,
complete with lists of tips and traps, to help hospitals adopt
standardized methods for evaluating and treating early sepsis patients.

Writer: Susan Gaidos

To arrange an interview with NIGMS Director Jeremy M. Berg, Ph.D.,
contact the NIGMS Office of Communications and Public Liaison at
301-496-7301. For more information about NIGMS funding of research
on sepsis, visit http://www.nigms.nih.gov/Initiatives/Trauma/.

NIGMS (http://www.nigms.nih.gov),
a component of the National Institutes of Health, supports basic
biomedical research that is the foundation for advances in disease
diagnosis, treatment, and prevention.

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 www.nih.gov.

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