Surviving Sepsis Campaign Linked to Decreased Hospital Mortality

Deborah Brauser

January 25, 2010

January 25, 2010 (Miami Beach, Florida) — Participation in the Surviving Sepsis Campaign performance improvement initiative appears to be associated with an overall reduction in hospital mortality from severe sepsis and septic shock, according to a new study published simultaneously in the February issues of Critical Care Medicine and Intensive Care Medicine.

The results were also presented in a symposium here at the Society of Critical Care Medicine (SCCM) 39th Critical Care Congress.

"Severe sepsis accounts for 20% of all admissions to intensive care units [ICUs] and is the leading cause of death in noncardiac ICUs," write Mitchell M. Levy, MD, professor of medicine in the Division of Pulmonary, Sleep, and Critical Care Medicine at Brown University School of Medicine in Providence, Rhode Island, and immediate past president of the SCCM, and colleagues.

With the goal of improving sepsis outcomes through standardized care, the SCCM, the European Society of Intensive Care Medicine (ESICM), and the International Sepsis Forum launched the Surviving Sepsis Campaign in 2002 and developed a set of evidence-based guideline recommendations. They were first released in 2004.

The campaign's updated 2008 guidelines are currently endorsed by 18 professional societies and have been implemented voluntarily in the United States, Europe, and South America.

However, "guidelines are rarely, if ever, integrated into bedside practice in a timely fashion," write the study authors.

"According to the literature, that is very difficult to do," admitted Dr. Levy in an interview with Medscape Critical Care. "Guidelines often end up collecting dust on clinicians' desks, which is something we were determined to not have happen. Although it's most ideal if all 48 guideline recommendations are used to determine what's best for the patients and are then applied to them, we realize that that can be hard to do. So we developed a model to help clinicians do the right thing."

This model includes 2 "bundles" — the sepsis resuscitation bundle, with tasks to be completed within the first 6 hours, and the management bundle, with actions to be completed within the first 24 hours.

In addition to the bundles, activities designed to increase compliance included creating educational materials, recruiting local physician and nurse "champions," and organizing regional launch meetings.

Study Finds Increased Compliance, Decreased Mortality

Wanting to examine the campaign participants' compliance rates with the bundled targets (the primary outcome) and the association with hospital mortality, the investigators examined registry data on 15,022 patients with severe sepsis or in septic shock from ICUs, emergency departments, and wards from 165 hospitals in 30 countries from January 2005 to March 2008. According to the investigators, this is the largest prospective series of severe sepsis patients yet to be studied.

By the end of the 2-year study, the investigators found that compliance almost tripled for the entire resuscitation bundle, from 10.9% in the first quarter to 31.3% (P < .0001), and increased almost 2-fold for the entire management bundle, from 18.4% to 36.1% (P = .008).

In addition, all individual bundle elements saw a significant increase in compliance, "except for inspiratory plateau pressure, which was high at baseline," write the authors.

"Our goal was to change clinical practice. We were pleased to see these improvements in compliance but we still have a long way to go," said Dr. Levy.

The investigators also found a decrease, from 37% to 30.8%, in the unadjusted hospitality mortality rate over the 2-year study (P = .001). "Plus, the adjusted odds ratio for mortality improved the longer a site participated in the campaign, resulting in an adjusted absolute drop of 0.8% per quarter and of 5.4% over 2 years (95% confidence interval, 2.5 - 8.4)," report the authors.

"Application of the 2 time-related bundles of care based on the Surviving Sepsis Campaign guidelines . . . [resulted] in measurable behavior change in the care of patients with severe sepsis and septic shock," the authors summarize. "Although not necessarily cause and effect, a reduction in reported hospital mortality rates was associated with participation."

Dr. Levy added: "We were very excited that the changes, consistent with guidelines, were associated with improved survival. It's a good example of how you can translate guidelines from a piece of paper into clinical practice."

Study limitations included its design. "Efficacy was inferred by observation of change over time, rather than through the more rigorous approach of a randomized controlled trial. Thus, conclusions . . .  must be interpreted with caution," write the authors.

They note that "many unanswered questions remain that could provide direction for future research, including the mortality trend in hospitals that have not implemented the bundles and confirmation of which components of the bundles reduce mortality."

Dr. Levy reported that his team will be applying to the National Institutes of Health for a grant to continue with a more focused intervention for the campaign to improve compliance even more.

Outside Comments

In an accompanying article, Simon Finfer, MBBS, FRCP, FCICM, professor in the Division of Critical Care at The George Institute for International Health at the University of Sydney, in Australia, writes: "The underlying goals of the campaign are as laudable today as when first enunciated in 2002."

He cautions, however, that the guidelines draw on older evidence, and a number of the bundle elements have been called into question after subsequent research. This includes 1 recent study that did not confirm that low-dose corticosteroids were beneficial, and others (including 1 he participated in) that found that targeting tight glycemic control might be harmful. "Increased uptake of the bundles will only represent 'continuous quality improvements' if the sum of the parts is beneficial to patients."

"In other words, there are issues with quite a few of the components of the bundles, which are now considered controversial, being promoted by the campaign," Dr. Finfer told Medscape Critical Care.

He also questioned the mortality rate data because there was no supervision during the screening, during the identifying of the patients, which may have introduced bias, or during the data submission.

Finally, Dr. Finfer writes that "increased awareness as a result of the campaign may be partly . . . responsible for reduced mortality [from sepsis] observed around the world." However, he notes, this mortality is also decreasing in countries such as Australia and New Zealand, which have not embraced the Surviving Sepsis Campaign guidelines. "In such circumstances, comparing crude mortality rates before and after an intervention ignores the underlying trend and will give rise to misleading conclusions."

In his conclusion, he writes: "A beneficial effect of the guidelines on patients' outcomes is currently unproven, and the primary evidence is not yet of sufficient quality to promote the guidelines as a global standard of care."

"A number of the bundle components are currently the subject of further trials and, clearly, once those trials are reported, we'll have a better idea of which of those elements should be retained in the treatment of patients with sepsis," said Dr. Finfer. "For now, I would say that individual clinicians will need to assess what they think of each individual component. I can't make a strong recommendation one way or the other about adopting the whole thing because the evidence just isn't there to do that."

"We've demonstrated that compliance with the elements of these bundles, even though some of them may be a bit debatable, is associated with improved survival," answered Dr. Levy. "Rather than being conservative and doing too little, the campaign demonstrates that doing a little bit more can be associated with better care for our patients."

The study was funded in part by Eli Lilly and Company, Edwards Lifesciences, Philips Medical Systems, the SCCM, and the ESICM. The study authors and Dr. Finfer have reported several relevant financial relationships, which are listed in the articles.

Society of Critical Care Medicine (SCCM) 39th Critical Care Congress. Presented January 13, 2010.

Crit Care Med. 2010;38:367-374, 683. Abstract, Abstract
Intensive Care Med. Published online January 13, 2010. Abstract, Abstract

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