Severe Sepsis Bundles

The Severe Sepsis Bundles are a distillation of the concepts and recommendations found in the practice guidlelines published by the SSC in 2004. They are designed to allow teams to follow the timing, sequence, and goals of the individual elements of care, in order to achieve the goal of a 25 percent reduction in mortality from severe sepsis. Individual hospitals should use the bundles to create customized protocols and pathways specific to their institutions.  However, all of the elements in the bundles must be incorporated in those protocols. The addition of other strategies not found in the bundles is not recommended.  The bundle will form the basis for the measurements that improvement teams will conduct to follow their progress as they make changes.

Hospitals should implement two different Severe Sepsis Bundles.  Each bundle articulates requirements for specific timeframes.

• Sepsis Resuscitation Bundle: Tasks that should begin immediately, but must be done within 6 hours for patients with severe sepsis or septic shock.
• Sepsis Management Bundle: Tasks that should begin immediately, but must be done within 24 hours for patients with severe sepsis or septic shock. 

Understanding the Bundle Concept

A "bundle" defined as a group of interventions related to a disease process that, when implemented together, result in better outcomes than when implemented individually. The science behind the elements of the bundle is so well-established that their implementation should be considered a generally accepted practice. Bundle components can be easily measured as completed or not completed. As such, the overall bundle—all of the elements taken together—can also be measured as completed or not completed.

In general, teams should take the bundles and build protocols for use at their own institutions.  The protocols should very closely mirror the bundles, but allow flexibility for logistical and other needs specific to the local hospital.  It is important to accurately mirror the content of the bundles in your approach because the measures used to assess your progress are designed around the specifications contained in the bundle elements.

The severe sepsis bundles form the core of the implementation phase of the Surviving Sepsis Campaign. Bundle science is the result of an integration of medical science and improvement work. Several years ago, as a part of an Institute for Healthcare Improvement (IHI) intiative on care in the ICU, participants considered a small set of evidence-based interventions for patients on mechanical ventilation. These interventions were: DVT prophylaxis, peptic ulcer disease prophylaxis, elevation of the head of the bed, and sedation vacation. This set of four interventions is known as the "ventilator bundle." Each of the teams measured the degree of compliance with the bundle, giving credit for medical contratindications. For each patient, a 1 or 0 was recorded, indicating whether or not all four elements of the bundle were implemented. A marked reduction in ventilator-associated pneumonia was noted when teams consistently implemented the bundle.

The use of the bundle prompted various disciplines in the ICU to reorganize their work. The results for ventilator-associated pneumonia were interesting and unexpected because for only two of the four elements in the bundle was there any scientific evidence that the element itself would reduce ventilator-associated pneumonia.This new method of clinical improvement - a bundle process that combines the best of medical science and improvement science - is developed in the following way   

   1. Identify a set of four to six evidence-based interventions that apply to a cohert of
       patients with a common disease or a common location.

   2. Develop the will in the providers to deliver the interventions every time they are 
       indicated.

   3. Measure compliance as "all" or "nothing."

   4. Redesign the delivery system to ensure the interventions in the bundle are delivered.

   5. Measure related outcomes to ascertain the effects of the changes in the
       delivery system.

The sepsis bundles were developed in just such a manner, based on the experience of the ventilator bundle. The goal now is to motivate the providers in your hospital to deliver the sepsis interventions every time they are indicated based on your policies. If the bundle elements are reliably performed the desired outcome of reducing sepsis-related deaths by 25% can be achieved.

The Bundle Elements

The sepsis bundles listed below distill the SSC practice guidelines into a manageable format for use at most institutions. They represent specific changes the campaign has identified as essential to the care of severely septic patients. Reliability following the bundles will eliminate the piecemeal or inappropriate application of standards for sepsis care that characterizes most clinical environments today.

The bundles are not ready-made protocols for individuals hospitals. Instead, hospitals should use them as a template to create customized protocols and pathways that will work well within their institutions (see Chapter 7 of the SSC Implementation manual). All of the elements in the bundles must be incorporated into those protocols. If all of the elements of the bundles are not incorporated into a customized protocol, performance on the measures will suffer.  Click here to view a bundle card that can be adpated for use in your hospital. Note the cards can be used as pocket guides or cut in the oval area by your printer for use on hospital lanyards or ID badges.

Sepsis Resuscitation Bundle

Evidence-based goals that must be completed within 6 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 seven bundle elements must be accomplished within the first 6 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 6 hours of identification of severe sepsis.

Bundle Element 1: Measure serum lactate

Bundle Element 2: Obtain blood cultures prior to antibiotic administration

• Blood Cultures Obtained 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

• Improve Time to Broad-Spectrum Antibiotics

Bundle Element 4: In the event of hypotension and/or serum lactate >4 mmol/L:

     a. Deliver an initial minimum of 20 mL/kg of crystalloid  or an equivalent                                         

      b. Apply vasopressors for hypotension not responding to initial fluid resuscitation to maintain mean arterial pressure (MAP) >65 mm Hg

• Treat Hypotension and/or Elevated Lactate with Fluids
• Apply Vasopressors for Ongoing Hypotension

Bundle Element 5: In the event of persistent hyptension despite fluid resuscitation (septic shock) and/or lactate >4 mmol/L:

      a. Achieve a central venous pressure (CVP) of >8 mm Hg

      b. Achieve a central venous oxygen saturation (ScvO2) > 70% or mixed venous oxygen saturation (SvO2) > 65%

• Maintain Adequate Central Venous Pressure
• Maintain Adequate Central Venous Oxygen Saturation

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 from 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.

• Administer Low-Dose Steroids by a Standard Policy 

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 >70, but <150 mg/dL

• Maintain Adequate Glycemic Control  

Bundle Element 4: Maintain a median inspiratory plateau pressure (IPP) <30 cm H20 for mechanically ventilated patients

• Prevent Excessive Inspiratory Plateau Pressures

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 is 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.