A Critical Review of the Government Mandated Cardiovascular Resuscitation Interventions for Sepsis (SEP-1)

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Abstract

The National Quality Forum (NQF) endorsed and CMS has instituted a performance measure to be applied to patients presenting with sepsis termed the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1). The primary purpose of this performance measure is to decrease hospital mortality and costs of care related to sepsis, severe sepsis and septic shock. Besides the need for antibiotic treatment within 3h, the performance measure originally required five interventions (both treatments and measures) related to the hemodynamic management of patients with sepsis: In adults with severe sepsis, initial lactate level measurement were to be performed within 3 hours of presentation, and repeat lactate level measurement performed within 6 hours of presentation, if the initial lactate level was elevated (i.e. serial lactate measures). In adults with septic shock, resuscitation with 30ml/kg crystalloid fluids was to be performed within 3 hours of presentation. Within 6 hours of presentation of septic shock, adults were to receive vasopressors if hypotension persisted after fluid administration. Also, if hypotension persisted after fluid administration , then a volume status and tissue perfusion assessment was required. According to the CMS performance measure, assessment of volume status and tissue perfusion required either a focused physical exam (vital signs, cardiopulmonary exam, capillary refill evaluation, peripheral pulse assessment and skin examination all must be performed), or any two of the following: measure CVP, measure ScvO2, bedside cardiovascular ultrasound, or passive leg raise or fluid challenge. CMS required that providers report on their institutions use of the interventions in this performance measure. This original performance measure was complex and required substantial hospital resources to achieve compliance. There were also wide concerns that its hemodynamic requirements were not supported by strong evidence. We previously performed a systematic review and meta-analysis and showed that indeed, only low quality evidence supported the individual hemodynamic interventions including those required at 6h to direct further hemodynamic support. This original study was published in 2018. CMS subsequently simplified SEP-1 and no longer required the hemodynamic interventions at 6h to guide further hemodynamic support. But questions still remained about even this simplified bundle including whether all patients should receive antibiotics within 3h and again whether all patients should receive a 30mL/kg volume infusion independent of comorbidities and seral lactate measures. Based on our prior study we were aware that some investigators had examined similar simplified sepsis bundles. We therefore performed another systematic review and analysis of these simplified sepsis bundles. We found that while such simplified bundles may improve survival, the timing of antibiotics and volumes of fluid required in these bundles varied and only one of 17 studies required serial lactate measures. Furthermore all studies were observational ones and provided only weak support for this therapeutic approach. This study has been completed and published. Work continues on assessing the effectiveness of the evolving CMS sepsis performance measure.