Protocolized Sepsis Care Is Not Helpful for Patients

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A protocol is an accepted or established code of procedure for a given situation or, more specifically in a medical context, the established procedure for carrying out a course of medical treatment. The publication of the highly influential study of the early goal-directed therapy resuscitation protocol for patients with severe sepsis and septic shock (1) and the subsequent dissemination of the Surviving Sepsis Guidelines (2) advocating a specific resuscitation protocol have been important milestones on the current pathway to reduced mortality for patients with sepsis. As the mortality rate for patients with sepsis has fallen significantly over recent years (3), it is tempting to assume that the implementation of this specific protocol of care for patients with sepsis has been instrumental in causing the fall in mortality. There are however many reasons to conclude that this is not the case. These include the significant heterogeneity within the population of patients with sepsis, which essentially precludes the delivery of a strict protocol of therapy. As well, the lack of evidence that either the components of the resuscitation protocol or the protocol as a whole are associated with improved patient-centered outcomes, and the fact that the improvements in mortality rates for patients with sepsis began prior to the introduction of the concept of protocolized care. These reasons all lead to the conclusion that the protocolized care currently being advocated for patients with sepsis is not helpful.
Protocolized care is most applicable to patients whose clinical course is anticipated to follow a predetermined pattern and who have a limited number of comorbidities (4). This is clearly not the case in sepsis. The updated definition of sepsis; life threatening organ dysfunction caused by a dysregulated host response to infection, which is operationalized as an increase in the Sequential Organ Failure Assessment score of 2 points or more (5), recognizes that the clinical manifestations of sepsis will vary from patient to patient. This may involve a worsening of cardiovascular, respiratory, neurologic, hematologic, or renal function. It is difficult for a single protocol to accommodate treatment recommendations to guide clinicians under the myriad of circumstances that fall under the clinical definition of sepsis. There is substantial heterogeneity associated with the causal infectious agent, the primary source of infection, the chronic comorbidities of the patients as well as diversity in the genetically determined host response to infection (6). It is not possible for a strict protocol to allow for the differing treatment needs of an otherwise healthy young female with urinary sepsis and a patient with relapsed hematologic malignancy, and neutropaenic sepsis those with chronic renal disease or heart failure, who present with severe community-acquired pneumonia.
In spite of these theoretic obstacles, a single resuscitation protocol for patients has been advocated and is based on the early goal-directed therapy approach to resuscitation for patients with sepsis (1). A number of the integral components of the resuscitation protocol have been assessed and found not to be associated with improved outcomes. The liberal use of blood transfusion, as used in the early goal-directed therapy protocol, was associated with no improvement in mortality in a study of 1,005 patients with severe sepsis (7). The adoption of a mean arterial blood pressure target of 65–70 mm Hg was associated with an increased requirement for renal replacement therapy in patients with preexisting chronic hypertension in a randomized clinical trial of 776 patients with septic shock (8), providing evidence that the single blood pressure target advocated in the early goal-directed therapy resuscitation protocol is not necessarily appropriate for all patients with sepsis.
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