Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
Become a Member | Sign in
Home>News>This Article

Sepsis Study Comparing Three Treatment Methods Shows Same Survival Rate

Published: Thursday, March 20, 2014
Last Updated: Thursday, March 20, 2014
Bookmark and Share
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.

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."

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,700+ scientific posters on ePosters
  • More than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Scientists Test New Gene Therapy for Vision Loss from a Mitochondrial Disease
NIH-funded study shows success in targeting mitochondrial DNA in mice.
Tuesday, October 06, 2015
NIH Framework Points The Way Forward For Developing The President’s Precision Medicine Initiative
The NIH Advisory Committee to the Director has presented to NIH Director Francis S. Collins, M.D., Ph.D., a detailed design framework for building a national research participant group, called a cohort, of 1 million or more Americans to expand our knowledge and practice of precision medicine.
Monday, September 21, 2015
Landmark NIH Study Shows Intensive Blood Pressure Management May Save Lives
Lower blood pressure target greatly reduces cardiovascular complications and deaths in older adults.
Saturday, September 12, 2015
NIH Study Finds Calorie Restriction Lowers Some Risk Factors for Age-Related Diseases
Two-year trial did not produce expected metabolic changes, but influenced other life span markers.
Wednesday, September 02, 2015
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
Thursday, August 27, 2015
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Thursday, August 27, 2015
Dr. Peter Kilmarx Appointed Deputy Director of Fogarty International Center
An expert in infectious disease research and HIV/AIDS prevention.
Wednesday, August 12, 2015
Benefits of Early Antiretroviral Therapy in HIV Infection
Scientists have explored the clinical importance of starting treatment early in individuals suffering with HIV.
Tuesday, August 11, 2015
Young South African Women can Adhere to Daily PrEP Regimen as HIV Prevention
NIH-funded study finds men in Bangkok, Harlem also successful in taking daily dose.
Saturday, July 25, 2015
Study Shows Promise of Precision Medicine for Most Common Type of Lymphoma
The study appeared online July 20, 2015, in Nature Medicine.
Tuesday, July 21, 2015
HIV Control Through Treatment Durably Prevents Heterosexual Transmission of Virus
NIH-funded trial proves suppressive antiretroviral therapy for HIV-infected people effective in protecting uninfected partners.
Tuesday, July 21, 2015
Early Antiretroviral Therapy Prevents Non-AIDS Outcomes in HIV-infected People
NIH-supported findings illustrate manifold benefit of therapy.
Tuesday, July 21, 2015
NIH-funded Vaccine for West Nile Virus Enters Human Clinical Trials
Enrollment is expected to be completed by December 2015.
Tuesday, July 07, 2015
In Blinding Eye Disease, Trash-Collecting Cells Go Awry, Accelerate Damage
NIH research points to microglia as potential therapeutic target in retinitis pigmentosa.
Friday, July 03, 2015
Boys More Likely to Have Antipsychotics Prescribed, Regardless of Age
NIH-funded study is the first look at antipsychotic prescriptions patterns in the U.S.
Thursday, July 02, 2015
Scientific News
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Study Removes Cancer Doubt for Multiple Sclerosis Drug
Researchers from Queen Mary University of London are calling on the medical community to reconsider developing a known drug to treat people with relapsing Multiple sclerosis after new evidence shows it does not increase the risk of cancer as previously thought.
Antibody Treatment Efficacious in Psoriasis
An experimental, biologic treatment, brodalumab, achieved 100 percent reduction in psoriasis symptoms in twice as many patients as a second, commonly used treatment, according to the results of a multicenter clinical trial led by Mount Sinai researchers.
Scientists Test New Gene Therapy for Vision Loss from a Mitochondrial Disease
NIH-funded study shows success in targeting mitochondrial DNA in mice.
HIV Patients Should Be Included in Early Clinical Trials of Anti-TB Drugs
Tuberculosis is the number one cause of death in HIV-infected patients in Africa and a leading cause of death in this population worldwide.
Multi-Gene Test Enables Some Breast Cancer Patients to Safely Avoid Chemotherapy
A major study is providing the best evidence to date that a 21-gene test done on the tumor can identify breast cancer patients who can safely avoid chemotherapy.
Low Dose Beta-Blockers As Effective As High Dose After a Heart Attack?
Heart attack patients live as long – or even longer – on one-quarter the suggested dose.
Antidepressants Plus Blood-Thinners Slow Down Brain Cancer
EPFL scientists have found that combining antidepressants with anticoagulants slows down brain tumors (gliomas) in mice.
Scroll Up
Scroll Down

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,700+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos