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.

-Niccolo Macchiavelli

The Italian philosopher’s words continue to resonate after writing The Prince five centuries ago. The Centers for Disease Control define sepsis as “the body’s overwhelming and life-threatening response to an infection, which can cause tissue damage, organ failure and death,” the cause of which is insufficient oxygen delivery to vital organs at the physiological level. Sepsis affects more than 1 million Americans annually, accounting for more than 250,000 deaths per year and $24 billion in health care costs in 2013 alone. The number and rate of hospitalizations has been rising steadily over the last two decades, likely due to a combination of factors such as increased awareness, diligent tracking, and an aging population. Other likely contributors include the spread of antibiotic-resistant organisms, an uptick of invasive procedures and broader use of immunosuppressive and chemotherapeutic agents.

In the last two decades, survivability of sepsis has improved alongside the increase in prevalence and awareness. 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. While the campaign has been a significant success, it also translates to an increased 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. Sepsis survivors have an increased risk of death compared with 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.

Severe sepsis was typically lethal prior to the advent of modern intensive care and techniques for the provision of vital organ support. Even with intensive care, mortality from septic shock often exceeded 80% as recently as 30 years ago. Advances in training, monitoring and vital organ support, along with prompt initiation of care, have stabilized mortality rates to between 20-30%. This progress has been encouraging. However, challenges remain in regards to the recognition and treatment of sepsis. Medicine for sepsis is complex and the potential for bad outcomes, ranging from long-term disability to death, are common. Moreover, medical experts have yet to reach a true consensus on treatment of the disease which complicates matters for juries. Sepsis treatment thus presents a rich environment for litigation.

Diagnosis

Diligence with patient history and clinical examination must be practiced when considering potential sources of infection, due to the fact that early sepsis symptoms are frequently vague. Fever, chills, fatigue, rapid breathing and heart rate and confusion are common early complaints. With the exception of fever, these symptoms may be associated with a multitude of non-infectious conditions.

While many different microbes can cause sepsis, bacteria are the most common offenders. Accounting for about half of all cases, pneumonia is the most common cause followed by intra-abdominal and urinary tract infections, and recent invasive procedures. Skin infections are also a common cause and most problematic in immunosuppressed patients; for example, a nursing home resident who experiences diabetic foot wounds and bedsores. 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)— these sources may be at work in the otherwise healthy intravenous drug abuser. Health-care providers should always consider the patient’s travel and social history for possible clues, and bring sepsis into consideration for cancer patients and patients on chronic steroid therapy.

Scoring Systems

Macchiavelli reinforces the idea that challenges in diagnosing sepsis have always existed. The medical profession continues to lack consensus even when it comes to definitions of severity— even moreso regarding the best tool or scoring system to assist with sepsis recognition. For the last 25 years, SIRS (systemic inflammatory response syndrome) criteria have formed this standard:

• temperature (too high or too low)
• elevated heart rate
• elevated respiratory rate
• white blood cell count (too high or too low)

When faced with infection, two or more of the above abnormalities indicate that the provider should consider sepsis. While these criteria were thought to rarely miss any cases, they also include 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.

Several other scoring systems have been suggested over the years but none 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 persisting controversies.

Written in 2001, Early goal-directed therapy (EGDT) is a seminal study that led to a major change in ICU management. EGDT became the standard in management almost immediately, not only with directives for appropriate recognition, resuscitation and treatment, but also for aggressive monitoring of several physiologic markers. The hypothesis was that these techniques would result in the maximal delivery of oxygen to deprived organs, and they became the new paradigm in intensive care management for years. We all embraced EGDT protocols because the theory was sound and patient outcomes improved— there was a significant decrease in mortality. With more invasive management and longer ICU stays, costs also increased. Only recently have we found that many of the techniques and monitoring parameters of EGDT, while sound in theory, are really not what have been improving outcomes.

In the last three years, three different and now universally-accepted studies have shown that none of the minutiae and theoretical treatment prescribed by EGDT, such as early transfusion, were responsible for improving outcomes. Each newer study demonstrated that compared with patients treated according to EGDT parameters, short and long-term outcomes were the same in patients treated 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. These patients required less invasive monitoring and shorter ICU stays, and costs also came down as a result. In the end, we all agree that the bedrock of sepsis care is formed by early detection, aggressive and appropriate resuscitation, and timely antibiotics. However, the means by which to further decrease sepsis mortality and mitigate long-term effects remain controversial.

Litigation

In the best of circumstances, one in five patients with severe sepsis will die. A high 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 sepsis diagnosis also presents opportunity for litigation.

We must continue to optimize our ability to diagnose sepsis and provide high-quality resuscitation. Complete reliance on diagnostic accuracy is inherently flawed. What’s paramount is a high index of suspicion and a low threshold for initiating accepted treatment initiatives, especially in populations at the highest risk for sepsis.

The majority of sepsis malpractice litigation stems from diagnostic errors and/or inappropriate or untimely management. 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 should be obtained before treatment. Some patients may present symptoms early and are thus candidates for outpatient management. Both provider and patient can decrease risk of litigation by being proactive with:

• Communication about the diagnosis
• Clear and concise discharge instructions, such as when to immediately return
• Documentation of this discussion
• Documentation of the patient’s understanding of instructions

Early symptoms of sepsis may be vague, such as subtle changes in the patient’s heart or respiratory rate. These patients may develop a more serious infection— if an appropriate discussion did not occur, or if it was not well-documented, a logical assumption is that the diagnosis was not initially considered. Communication after diagnosis and treatment is also important. The general public has little knowledge of what may lay ahead for themselves or a loved one after they leave the ICU. Survivors may remain afflicted for a lifetime; the disease may leave a multitude of permanent effects. This should also be addressed so that patients and families have reasonable expectations for a long-term prognosis. Communication 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. Sepsis can be difficult to recognize, and carries frequently catastrophic short and long-term outcomes for patients. This is complicated by both a lack of sufficient diagnostic tools, and a lack of consensus on appropriate care and monitoring. Providers should have a high index of suspicion for a sepsis diagnosis, initiate timely and appropriate treatment, and enhance communication with victims regarding diagnosis and potential outcomes to protect themselves against litigation.