By Dean L. Winslow, MD, FACP, FIDSA, FPIDS
Professor of Medicine, Division of General Medical Disciplines, Division of Infectious Diseases and Geographic Medicine, Stanford University
Dr. Winslow reports no financial relationships relevant to this field of study.
SYNOPSIS: The IDSA Sepsis Committee proposes that The Centers for Medicare & Medicaid Services’ Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) should be applied only to septic shock, not sepsis without shock.
SOURCE: Rhee C, Chiotos K, Cosgrove SE, et al. Infectious Diseases Society of America Position Paper: Recommended revisions to the National Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) sepsis quality measure. Clin infect Dis 2020; May 6. doi: 10.1093/cid/ciaa059. [Online ahead of print].
The Infectious Diseases Society of America (IDSA) Sepsis Committee’s position statement included the following concerns:
- The National Severe Sepsis and Septic Shock Early Management Bundle’s (SEP-1) requirement to immediately administer antibiotic therapy for all patients with possible sepsis risks, increasing excessive and unwarranted antibiotic administration.
- SEP-1 conflates the urgency of antibiotic administration for sepsis and septic shock.
- Bundle studies supporting SEP-1 are at high risk for bias and likely overestimate benefits.
- The definition for time zero is complex, subjective, and not evidence-based.
- Mandating lactate measurements for all patients with possible sepsis is inappropriate.
IDSA recommends the following changes to SEP-1:
- Sepsis without shock should be removed from SEP-1.
- Obtaining blood cultures before administering antibiotics should remain part of SEP-1.
- The interval from septic shock time zero to initiation of broad-spectrum antibacterial therapy should be one hour or less.
- SEP-1 should require hospitals to report time intervals.
- Lactate measurements should be removed from SEP-1.
There is no question that modern management of sepsis and septic shock has improved outcomes over the past two decades. The major recommendations that came from the important papers on sepsis management and early goal-directed therapy (and have withstood the test of time) emphasized timely administration of antibiotics and adequate volume resuscitation in conjunction with the use of vasopressors and general supportive care. The Society of Critical Care Medicine has taken the lead on developing specific standards in the context of The Surviving Sepsis Campaign. Although members of the IDSA participate on the committee along with pulmonary and critical care medicine specialists, some irreconcilable differences arose during the 2017 revision, prompting IDSA to publish its concerns.1
An important concern that many infectious disease specialists have is that these guidelines are codified as bundles tied to national reporting of hospitals’ quality measures (and reimbursement). Because of the nonspecific nature of “sepsis,” many patients’ non-bacterial infections and noninfectious illnesses often trigger the sepsis bundles. Unfortunately, adherence to these quality measures is not optional, and clinicians feel obligated to follow these guidelines to avoid being “dinged.”
A classic case I cared for exemplified many of the problems of rigid adherence to sepsis bundles. The patient was a 90-year-old woman with hypertension and heart failure with preserved ejection fraction who had been confirmed to have influenza A the day before by polymerase chain reaction (PCR) and had been started on oseltamivir. However, she developed wheezing and was transported from a skilled nursing facility to the emergency department. She was mildly febrile and tachycardic, and her blood pressure was 190/100 mmHg. She was wheezing and had bibasilar crackles. Her chest X-ray was suggestive of heart failure, but without evidence of pneumonia. Her white blood cell count was elevated. An intravenous line (IV) was started and she was given albuterol by nebulizer.
Because the constellation of findings triggered “the sepsis bundle,” she had a blood lactate drawn (which was now elevated because of the inhaled beta agonists she had just received). Even though bacterial sepsis was unlikely, she was slammed with IV vancomycin + piperacillin/tazobactam and given 2.1 liters of IV normal saline. By the time my inpatient team and I came down to the ED to admit her, she was in florid pulmonary edema, and we needed to give her IV furosemide and she required bilevel positive airway pressure (BiPAP) for a few hours. We also stopped her antibiotics.
When I gently chastised the house staff, they said that they agreed this treatment was inappropriate, but they did not want to get “dinged” if they did not follow the bundle. IDSA’s position paper is published to help persuade The Centers for Medicare & Medicaid Services to make appropriate modifications to SEP-1 so that the helpful aspects of the bundle are preserved but we do not hurt patients with inappropriate treatment.
- IDSA Sepsis Task Force. Infectious Diseases Society of America (IDSA) Position Statement: Why IDSA did not endorse the Surviving Sepsis Campaign Guidelines. Clin Infect Dis 2018;66:1631-1635.