SEVERE SEPSIS BUNDLES
The changes called for on these pages mirror the individual elements of the Severe Sepsis Bundles. Taken together, we believe these changes will substantially reduce mortality due to severe sepsis. The Severe Sepsis Bundles are a distillation of the evidence-based recommendations found in the 2008 practice guidelines promulgated by the Surviving Sepsis Campaign.
Ranking the Evidence
Choosing therapies to treat patients with severe sepsis and septic shock requires an organized approach to evaluating the evidence. The Sepsis Resuscitation and Management Bundles were derived from the 2008 Surviving Sepsis Campaign Guidelines which incorporated the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system approach to evaluating the literature.
Understanding the Bundle Concept
A "bundle" is a group of therapies for a given disease that, when implemented together, may result in better outcomes than if implemented individually. In a bundle, the individual elements included are built around best evidence-based practices. The science supporting the individual treatment strategies in a bundle is sufficiently mature such that implementation of the approach should be considered either best practice or a reasonable and generally accepted practice.
The purpose of creating a bundle strategy is to clearly articulate a therapeutic framework that will function as a lever for change. We anticipate that making the Severe Sepsis Bundles standard practice will eliminate the piecemeal or chaotically applied of standards for sepsis care that characterize many clinical environments today.
The Severe Sepsis Bundles have been designed with the hope to allow teams to follow the timing, sequence, and goals in the bundles, to achieve a 25 percent reduction in mortality due to severe sepsis or septic shock.
We hope hospitals will use the bundles to create customized protocols and pathways that will function well within their institutions. However, we encourage that each of the elements in the bundles be incorporated in those protocols. Optimally, the protocols should closely mirror the bundles, but allow flexibility for logistical and other needs specific to each hospital. The reason to include the therapies specified in the bundles in your protocol for care is that if you use our measurement strategies and database, you will be measured as compliant (or non-compliant) with those elements. Therefore, if not all of the elements of the bundles are incorporated into your customized protocol, your performance on the quality indicators we have designed will suffer. In addition, we believe the elements to be the best strategy to improve care.
There are two Severe Sepsis Bundles. Each bundle articulates objectives to be accomplished within specific timeframes. The bundles have been developed based upon the 2008 Surviving Sepsis Campaign Guidelines for the Management of Severe Sepsis and Septic Shock. The Guidelines incorporated an evidence-based review of the literature and ranked the strength of each recommendation. In the following pages, the grading of the evidence supporting each element is noted and a separate page describes the evidence ranking process.
Sepsis Resuscitation Bundle
The Sepsis Resuscitation Bundle describes seven tasks that should begin immediately, but must be accomplished within the first 6 hours of presentation for patients with severe sepsis or septic shock. Some items may not be completed if the clinical conditions described in the bundle do not prevail in a particular case, but clinicians should assess for them. The goal is to perform all indicated tasks 100 percent of the time within the first 6 hours of identification of severe sepsis.
Bundle Element 1
Measure serum lactate
Bundle Element 2
Obtain blood cultures prior to antibiotic administration
Bundle Element 3
Administer broad-spectrum antibiotic within 3 hours of ED admission and within 1 hour of non-ED admission
Bundle Element 4
Treat hypotension and/or elevated lactate with fluids
In the event of hypotension and/or serum lactate >4 mmol/L:
- Deliver an initial minimum of 20 mL/kg of crystalloid or an equivalent
- Apply vasopressors for hypotension not responding to initial fluid resuscitation to maintain mean
arterial pressure (MAP) >65 mm Hg
Apply vasopressors for ongoing hypotension
Bundle Element 5
Maintain adequate central venous pressure
Maintain adequate central venous oxygen saturation
In the event of persistent hypotension despite fluid resuscitation (septic shock) and/or lactate >4 mmol/L:
- Achieve a central venous pressure (CVP) of >8 mm Hg
- Achieve a central venous oxygen saturation (ScvO2) >70% or mixed venous oxygen saturation (SvO2) >65%
Sepsis Management Bundle
Evidence-based goals that must be completed within 24 hours for patients with severe sepsis, septic shock and/or lactate > 4 mmol/L (36 mg/dL). For patients with severe sepsis, as many as four bundle elements must be accomplished within the first 24 hours of presentation. Some items may not be completed if the clinical conditions described in the bundle do not prevail, but clinicians must assess for them. The goal is to perform all indicated tasks 100 percent of the time within the first 24 hours of presentation:
Bundle Element 1
Administer low-dose steroids for septic shock in accordance with a standardized ICU policy.
If not administered, document why the patient did not qualify for low-dose steroids based upon the standardized protocol.
Bundle Element 2
Administer recombinant human activated protein C (rhAPC) in accordance with a standardized ICU policy. If not administered, document why the patient did not qualify for rhAPC.
Bundle Element 3
Maintain glucose control lower limit of normal, but <180 mg/dL(10 mmol/L)
Click here to view 2009 Statement on Glucose Control
Bundle Element 4
Maintain a median inspiratory plateau pressure (IPP) <30 cm H20 for mechanically ventilated patients
Measuring and Documenting the Bundles
Using the SSC performance improvement database will help your team and hospital evaluate improvements necessary to consistently achieve specific bundle elements. Engaging PDSA (Plan, Do, Study, Act) cycles for each bundle element where performance is lower than desired, will assist the team to develop/alter protocols and order sets and put systems into place to correct deviations (see article on PDSA cycles and the SSC).
The performance improvement database allows users to enter data directly from individual patient charts. In the background, the SSC database aggregates that information across units, institutions, or hospital systems gauging success with the SSC quality indicators. At the end of each month, or any time desired, the data are transformed into bundle compliance graphs. This offers the visual stimulation necessary to motivate the team toward positive change. Posting the graphs presents opportunities for discussions at meetings and in the unit or emergency department so that protocol adjustments, perhaps equipment purchases, or other implementation approaches can be acted upon. Entering data into the database concurrently will reveal in real time if the bundles were achieved or if policy was followed. Retrospective data collection is not ideal because all too often, the care memory can be lost. The campaign recommends that information is entered directly into the database, not placed onto a paper tool first and then entered. This duplicative effort yields no benefit.
The Severe Sepsis Quality Indicators should be used in conjunction with the bundles to help improvement teams understand the measures that will be used to evaluate their progress in improving the care of severely septic patients.