Sepsis shortfalls: How current sepsis care and measurement is lacking

Sepsis, a deadly complication caused by the body's extreme response to infection, poses a major issue for hospitals as the condition is both difficult and expensive to treat.

Sepsis accounts for nearly $24 billion in annual healthcare costs, according to a 2016 study from the Healthcare Cost and Utilization Project. The life-threatening illness is also very common — more than 1.5 million Americans get sepsis annually, and about 250,000 people die from the complication, according to the CDC.

This article is sponsored by La Jolla Pharmaceutical Company.

"Sepsis can attack anyone at anytime, young or old," said George Tidmarsh, MD, PhD, president and CEO of La Jolla Pharmaceutical Company, during an April 13 roundtable discussion at Becker's Hospital Review 9th Annual Meeting in Chicago. "Previously healthy patients can be dead within hours. So it is a really big — and costly — problem."

In a series of three separate roundtable discussions, Dr. Tidmarsh and his colleague, Steve Chen, MD, La Jolla's vice president of medical affairs, joined a total of 45 hospital C-suite leaders from across the country to assess the challenges and opportunities associated with recommended sepsis protocols.

The current state of sepsis care

Drs. Tidmarsh and Chen began the discussions by outlining current initiatives and regulations aimed at improving sepsis care.

"Perhaps the most well-known initiative is the Surviving Sepsis Campaign, which the European Society of Intensive Care Medicine, the International Sepsis Forum and the Society of Critical Care Medicine launched in 2002 as a collaborative initiative to reduce sepsis-related mortality," Dr. Chen said.

The campaign releases new sepsis guidelines every four years, with the latest update occurring in 2016. The campaign's care guidelines are organized into three- and six-hour bundles, which contain a set of care elements clinicians should implement after a patient presents with symptoms of severe sepsis or septic shock.

Three-hour bundle (to be completed within 3 hours of patient's presentation):

  • Measure lactate level
  • Obtain blood cultures
  • Administer broad spectrum antibiotics (after blood cultures obtained)
  • Administer 30 milliliters per kilogram of crystalloid for hypotension or lactate greater than or equal to 4 millimoles per liter

Six-hour bundle (to be completed within 6 hours):

  • Initiate vasopressors (for hypotension not responding to initial fluid resuscitation) to maintain a mean arterial pressure of at least 65 mmHg
  • In the event of persistent hypotension after initial fluid administration (mean arterial pressure of less than 65 mmHg) or if initial lactate was greater than 4 millimoles per liter, reassess volume status and tissue perfusion and document findings
  • Remeasure lactate if initial lactate was elevated

Individual state mandates also exist to ensure hospitals are following best practices when treating sepsis patients. In 2013, New York became the first state to implement Rory's Regulations, named after 12-year-old Rory Staunton who died from sepsis in 2012. Emergency department physicians failed to identify his septic shock symptoms and sent Rory home. He died four days later.

Rory's Regulations require every hospital in New York to follow evidence-based clinical practice protocols for timely sepsis identification and management. The state has achieved significant improvements in sepsis care and outcomes after implementing Rory's Regulations, along with a statewide sepsis improvement care in 2014. A 2017 report from the New York State Department of Health found hospitals' utilization of sepsis protocols increased from 73.7 percent in 2014 to 84.7 percent in 2016. Compliance with the timely management of sepsis also increased from 41.5 percent to 55.2 percent over the same time period, while sepsis-related mortality dropped from 30.2 percent to 25.4 percent statewide.

Rory's Regulations also served as a catalyst for federal oversight on sepsis care. In 2015, CMS rolled out core measures for sepsis as part of the Hospital Inpatient Quality Reporting program. The core measures, which every Joint Commission-accredited hospital in the U.S. must follow, closely align with the Surviving Sepsis Campaign's three- and six-hour bundles. Hospitals that fail to comply with these sepsis protocols are penalized with a smaller reimbursement.

Room for improvement

While these interventions have helped hospitals nationwide improve initial sepsis identification and resuscitation, current protocols do not offer guidance on the entire sepsis care process, especially for patients who develop septic shock, according to Dr. Chen.

"Most protocols right now focus on the initial stages of sepsis," he said. "There is not a lot of focus on the end stages of sepsis. ... We know implementation of early sepsis recognition and treatment works. But what about for patients who slip through the cracks and start developing shock? That is a whole other paradigm not yet addressed by quality measures."

Septic shock, which occurs when a sepsis patient experiences a significant drop in blood pressure, costs two to three times more to treat than other acute conditions requiring hospitalization, according to Dr. Tidmarsh. Mortality rates for septic shock also exceed those of most other conditions. A 2014 study published in the Journal of Critical Care found septic shock patients in the intensive care unit had a 30-day mortality rate of about 50 percent, compared to just a 14 percent 30-day mortality rate for heart attack patients and a 12 percent rate for congestive heart failure patients based on national Medicare data.

"Sepsis-related mortality rates will not decrease unless hospitals improve sepsis care beyond the six-hour point," Dr. Tidmarsh said.

However, the second half of the sepsis care playbook, which should address shock, is relatively empty. The U.S. healthcare system lacks a unified approach for treating patients with septic shock, which creates a lot of opportunity to assess quality measures or interventions that may improve septic shock outcomes.

Real-world findings on septic shock management

The Surviving Sepsis Campaign recommends physicians keep septic shock patients' mean arterial pressure at 65 mmHg or higher, which is one of the few treatment measures for addressing septic shock care. However, few studies have investigated MAP control in a real-world setting, according to Dr. Chen.

La Jolla sought to assess how well hospitals can actually control MAP — and if it makes a difference in sepsis shock care — by analyzing data from the Medical Information Mart for Intensive Care, also known as MIMIC III. The public database contains detailed information for 61,532 ICU admissions conducted at Boston-based Beth Israel Deaconess Medical Center between 2001 and 2012.

La Jolla identified 5,725 ICU admissions from the database in which adult septic shock patients were treated with vasopressors for more than six hours. Additional patient selection parameters mirrored the clinical trial entry criteria for La Jolla's own vasopressor GIAPREZATM (angiotensin II), which the FDA approved in December 2017.

La Jolla looked at the ICU admissions data to identify periods of time in which patients' MAP fell below the recommended level. "What was surprising to us was that a very large number of patients had continuous readings below the target MAP," Dr. Tidmarsh said.

A majority (93.8 percent) of patients had MAP drop below the recommended threshold for any period of time. Nearly 62.3 percent of patients' MAP fell below the target level for over two continuous hours, and 22.1 percent of patients saw this reading fall below the threshold for six continuous hours. Even when the target MAP level was lowered to 55 mmHg, 68.6 percent of patients still fell below the level at least once during their hospital stay.

"This data suggests MAP is not well managed, even at top-tier hospital like Beth Israel Deaconess Medical Center," Dr. Tidmarsh said. "We don't know the reason for this. Maybe clinicians don't have the right tools, etc., but the fact is, it happens."

To assess the potential consequences of poor MAP control, La Jolla also analyzed mortality rates for the same group of patients. Patients whose MAP fell below the 65 mmHg threshold for two continuous hours had a 22.1 percent ICU mortality rate. This figure skyrocketed to 57.4 percent for patients whose map fell below the threshold for 12 continuous hours.

"The more time spent below the target MAP of 65, the more likely patients will die," Dr. Chen said, adding that La Jolla's analysis is one of the first to link time below target MAP to hard outcomes for patients in a real-world database.

Healthcare executives weigh in

These findings were not a surprise to the hospital and health system executives at the roundtable discussions, who shared their own challenges in treating sepsis patients and adhering to the bundle guidelines.

Several leaders highlighted the difficulty of getting ED physicians to follow the sepsis protocols.

"Ninety-two percent of our septic shock patients come through the ED," said the senior risk management and patient safety officer at a large acute care hospital in the West. "Many of them come in walking and talking. They don't look sick, so our ED physicians don't start the sepsis protocol. Our biggest barrier to improving compliance is physicians never know what happens to the patients."

The hospital started a process to report septic shock patients' outcomes back to ED physicians. This system places more accountability on physicians to implement the sepsis protocols and helps them realize their actions in the ED can greatly affect a patient's outcome, the executive said.

In other cases, clinicians may follow the sepsis protocols, but fail to properly record their actions in the EHR, according to the vice president of patient care services and chief nursing officer at an acute care hospital in the Northeast.

"Even though we're giving the recommended amount of fluids, etc., our nurses aren't always documenting it because it's a bit difficult to do in our EHR," she said. "So while we have 100 percent compliance for starting the bundles, our overall compliance is not as high as it could be."

The associate CMO at a regional care hospital in the Midwest said her hospital has been tracking MAP in the ICU since the 1980s, but it's still a challenge. The hospital relies on a fairly manual process to track clinical actions associated with MAP, which doesn't interface well with its EHR, so it's difficult to pull out actionable insights.

"It's hard to figure out if our actions really matter," she said. "They seem to, but it's hard to drill down because of how the data are tracked."

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