In this month’s New England Journal of Medicine, Seymour, et al examine the effects of a set of state regulations in New York which are the first of their kind. Enacted in 2013, these regulations mandate protocols for the timely treatment of sepsis. Many of these protocols are already in place in many hospitals across the country, and there are incentives to enact these sepsis protocols including JCAHO evaluations, etc on a federal level. In addition, there are practice guidelines for the treatment of sepsis published by the Infectious Diseases Society of America (IDSA) and the Society of Critical Care Medicine in 2014 Link Here. However, for the first time, these state laws seek to enact guidelines into state law which is a dangerous precedent. Presently multiple states are considering enacting similar regulations.
You see the difference between guidelines and regulations exists in the flexibility of clinicians’ decision making with guidelines and the inflexibility of regulations. Sepsis is a diagnosis based on criteria that obviously include the presence of an infection along with certain inflammatory response factors. Because it is not always known for certain that there exists an infection or the site of that infection, sepsis is a nebulous diagnosis especially at the beginning of a hospital stay. Often the diagnosis of sepsis is made on the possibility of infection. When you have positive blood cultures (bacteremia or bacteria in the blood stream) the diagnosis is concrete, but bacteremia is present in less than 20% of cases of sepsis. For this reason, there is a gross over-diagnosis of sepsis in hospitals and rightly so, because physicians do not want to miss the diagnosis. However, there is also an inherent overuse of antibiotics because of this over-diagnosis. The study in NEJM seeks to monitor this law to ascertain the benefits and the lack of benefits of the different regulations enacted in New York.
In general, with the possible diagnosis of sepsis, guidelines already mandate the use of blood cultures, timely administration of antibiotics, measurement of serum lactate, and aggressive fluid resuscitation. The New York state laws codify these guidelines into law making them inflexible. See this commentary. Other studies have measured the over-diagnosis of sepsis including this one. So let’s briefly look at what is found in the article.
It is widely held that it is the resuscitation that matters in survival of sepsis and there are some studies to corroborate this. This is why it makes sense to use lactate as a marker for hypoperfusion and therefore the need for intravenous fluids. In this study it was found that completing the bundle of orders for sepsis mattered, However, only the timing of the first dose of antibiotics resulted in less mortality and not the timing of intravenous fluids. This is a rather disconcerting finding, because the guidelines and the New York laws are centered around this bolus of fluids concept that it is the resuscitation that matters. Instead, it is what we have been doing for decades and that is, giving appropriate antibiotics quickly when the diagnosis of sepsis is possible. However, I don’t think this will change the guidelines and our practice because it makes sense to give intravenous fluid boluses for those with evidence of hypoperfusion.