Sepsis: Controversies and Risks
'as the physicians say it happens in hectic fever, that in the beginning of the malady it is easy to cure but difficult to detect, but in the course of time, not having been either detected or treated in the beginning, it becomes easy to detect but difficult to cure'
Five centuries after writing The Prince, the Italian philosopher's words continue to resonate. The Centers for Disease Control define sepsis as "the body's overwhelming and life-threatening response to an infection, which can tissue damage, organ failure and death." At the physiologic level, this is caused by lack of sufficient oxygen delivery to the vital organs. Sepsis affects more than 1 million Americans annually, accounting for greater than 250,000 deaths per year. (1) This accounted for $24 billion in health care costs in 2013. The number and rate of hospitalizations has been rising steadily over the last two decades, likely due to a combination of factors including increased awareness, diligent tracking and an aging population. Spread of antibiotic-resistant organisms, upsurge of invasive procedures and broader use of immunosuppressive and chemotherapeutic agents are also likely contributors.
With the increase in prevalence and awareness has come improved survivability over the last two decades. Efforts such as the "Surviving Sepsis Campaign," initiated by the Society of Critical Care Medicine, have helped promote early recognition and improve clinical processes around sepsis. This campaign has been a significant success to be sure, but it also means an increase in the number of patients who may be living with the long-term and potentially devastating after effects of sepsis, such as cognitive impairment, organ dysfunction and limb amputation. Survivors have an increased risk of death over the general population even several years after an event. Five year mortality rates from all causes for sepsis survivors is double that of other hospitalized patients.(2)
Progress has been encouraging but challenges remain going forward regarding the recognition and treatment of sepsis. The medicine is complex and the potential for bad outcomes ranging from long-term disability to death are common, leading to a rich environment for litigation. Sepsis is a complicated subject for health care providers. Imagine the difficulties for juries sorting through the testimony of medical experts whom, frankly, have not yet reached a true consensus.
Diligence with both patient history and clinical examination must be practiced when considering potential sources of infection due to the fact that early presenting symptoms are frequently vague. Fever, chills, fatigue, rapid breathing and heart rate and confusion are common early complaints. Outside of fever, these symptoms may be associated with a multitude of non-infectious conditions. Many different microbes can cause sepsis, but bacteria are the most common offenders. Pneumonia is the most common cause, accounting for about half of all cases, followed by intra-abdominal and urinary tract infections. Recent invasive procedure is another common cause as are skin infections, most concerning in the immunosuppressed such as seen with diabetic foot wounds and bedsores in the the severely debilitated nursing home resident. More rare and subtle sources must be considered in at risk populations, such as endocarditis (infection of the heart valves) and epidural abscess (infection in the spinal canal), that may be seen in the otherwise healthy intravenous drug abuser. Providers should never ignore a good travel and social history for possible clues. Cancer patients and patients on chronic steroid therapy should also raise suspicion and bring sepsis into consideration.
As inferred by Mr Macchiavelli, challenges in diagnosing sepsis seem to have always existed. The medical profession continues to lack consensus even when it comes to definitions of severity, much less on the best tool or scoring system to assist with recognition. For the last 25 years, SIRS (systemic inflammatory response syndrome) criteria has essentially been the standard. These are four criteria, including temperature (too high or too low), elevated heart rate, elevated respiratory rate and white blood cell count (too high or too low); two or more abnormalities present in the setting of infection is the trigger to consider sepsis. These criteria were thought to rarely miss any cases, but we're also including many cases that were not in fact sepsis. Only recently has it been shown that this scoring tool may not be as sensitive as once thought. Over the years, several other scoring systems have been suggested none of which have stood up to scrutiny. Articles have suggested that physician judgement may be as efficient as any set criteria or scoring system. Most recently, the Society for Critical Care has posited new definitions of sepsis along with a new scoring tool that has yet to be universally endorsed. The American College of Emergency Physicians, while endorsing the guidelines as whole, did not back these changes. This lack of clarity only serves to highlight the controversies that persist.
Before the advent of modern intensive care and techniques for the provision of vital organ support, severe sepsis was typically lethal. Even with intensive care, mortality from septic shock would often exceed 80% as recently as 30 years ago. Advances in training, monitoring and vital organ support along with prompt initiation of care have improved to the point where mortality has steadied between 20-30%.(3) The seminal study that led to a major change in ICU management was written in 2001. Early goal-directed therapy (EGDT) almost immediately became the standard in management, with directives for not only appropriate recognition, resuscitation and treatment, but aggressive monitoring of several physiologic markers under the hypothesis that these parameters would reflect the maximal delivery of oxygen to the deprived organs. As can be seen in the table, the discussion of these details is too arcane for this forum, but these techniques became the new paradigm in intensive care management for years. We all embraced these protocols because the theory was sound and patient outcomes improved, specifically a significant decrease in mortality. With more invasive management and longer ICU stays, costs also increased as a matter of course. Only recently have we found that many of the techniques and monitoring parameters of EGDT, while seemingly sound in theory, are really not what have been improving outcomes.
In the last three years, three different studies that are now universally accepted have shown that none of the minutiae and theoretical treatment, such as early transfusion, prescribed by EGDT were responsible for improving outcomes. Each newer study, in its own design, showed that outcomes in the short and long-term were the same with early initiation of appropriate antibiotics, appropriate use of aggressive fluid resuscitation as monitored by a single lab parameter (lactic acid, produced by tissues when oxygen debt exists) and close observation of clinical signals of adequate oxygen delivery to vital organs. Patients were being saved and with less invasive monitoring and shorter ICU stays, costs also came down as a result. In the end, we all agree that early detection, aggressive and appropriate resuscitation along with timely antibiotics form the bedrock of sepsis care. How to further decrease mortality and mitigate the long-term effects of this major insult to a life remain controversial.
In the best of circumstances, one in five patients with overwhelming sepsis die. Furthermore a large percentage of survivors suffer permanent effects and higher risk of deterioration going forward. If my profession cannot come to a consensus regarding evaluation, resuscitation and long-term care, it stands to reason that this diagnosis also presents opportunity for litigation.
Primarily, it is paramount that we continue to optimize our ability to diagnose sepsis and that we continue to provide high-quality resuscitation. Complete reliance on our diagnostic accuracy is inherently flawed. High index of suspicion and low threshold for initiating accepted treatment initiatives is paramount, especially in populations at highest risk for sepsis. It is well-established that diagnostic errors and/or inappropriate or untimely management account for the majority of malpractice litigation centered around the septic patient. Aggressive treatment modalities, such as invasive procedures and medications to support blood pressure, also pose risk for injury. Patients and families should be made aware of the risks and appropriate consent obtained for treatment. Some patients may present early in a course and are candidates for outpatient management. Communication about the diagnosis, clear and concise discharge instructions for when to immediately return and documentation of both said discussion and that the patient is capable of and expresses understanding will go a long way in decreasing risk for both provider and patient. Early symptoms may be vague and early signs may be subtle changes in heart or respiratory rate. These patients may develop a more serious infection and if an appropriate discussion did not occur or was not well-documented, a logical assumption is that the diagnosis was not considered initially. Communication is also important after the diagnosis is made and quality treatment rendered. The general public has little knowledge what may lay ahead for themselves or a loved one after they leave for the ICU. Survivors may remain afflicted for a lifetime. The disease itself may leave a multitude of permanent effects. This should also be addressed so that patients and families have reasonable expectations for the long-term prognosis. It is well known that communications between providers and patients/families both improves patient outcomes and reduces risk of litigation.
Sepsis is a serious medical condition that affects a large and growing number of citizens each year. It can be difficult to recognize and carries frequently catastrophic short and long-term outcomes for patients. This is complicated by the lack of sufficient diagnostic tools and lack of consensus on appropriate care and monitoring of response to care. In order to reduce the likelihood and improve defensibility of litigation, providers should have a high index of suspicion for the diagnosis, initiate timely and appropriate treatment and enhance communication with victims regarding the diagnosis and potential outcomes.
Centers for Disease Control and Prevention. Sepsis Questions and Answers. 5 October 2015
Angus DC. “The Lingering Consequences of Sepsis: A hidden Public Health Disaster?” JAMA. 2010; 304(16): 1833-34.
Angus DC, van der Pol T. “Severe Sepsis and Septic Shock.” N Engl J Med 2013; 369: 840-51.