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      Association Between the New York Sepsis Care Mandate and In-Hospital Mortality for Pediatric Sepsis

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          Abstract

          <div class="section"> <a class="named-anchor" id="S1"> <!-- named anchor --> </a> <h5 class="section-title" id="d9338807e275">IMPORTANCE</h5> <p id="P10">The death of a pediatric patient with sepsis motivated New York to mandate statewide sepsis treatment in 2013. The mandate included a 1-hour bundle of blood cultures, broad-spectrum antibiotics, and a 20-mL/kg intravenous fluid bolus. Whether completing the bundle elements within 1 hour improves outcomes is unclear. </p> </div><div class="section"> <a class="named-anchor" id="S2"> <!-- named anchor --> </a> <h5 class="section-title" id="d9338807e280">OBJECTIVE</h5> <p id="P11">To determine the risk-adjusted association between completing the 1-hour pediatric sepsis bundle and individual bundle elements with in-hospital mortality. </p> </div><div class="section"> <a class="named-anchor" id="S3"> <!-- named anchor --> </a> <h5 class="section-title" id="d9338807e285">DESIGN, SETTINGS, AND PARTICIPANTS</h5> <p id="P12">Statewide cohort study conducted from April 1, 2014, to December 31, 2016, in emergency departments, inpatient units, and intensive care units across New York State. A total of 1179 patients aged 18 years and younger with sepsis and septic shock reported to the New York State Department of Health who had a sepsis protocol initiated were included. </p> </div><div class="section"> <a class="named-anchor" id="S4"> <!-- named anchor --> </a> <h5 class="section-title" id="d9338807e290">EXPOSURES</h5> <p id="P13">Completion of a 1-hour sepsis bundle within 1 hour compared with not completing the 1-hour sepsis bundle within 1 hour. </p> </div><div class="section"> <a class="named-anchor" id="S5"> <!-- named anchor --> </a> <h5 class="section-title" id="d9338807e295">MAIN OUTCOMES AND MEASURES</h5> <p id="P14">Risk-adjusted in-hospital mortality.</p> </div><div class="section"> <a class="named-anchor" id="S6"> <!-- named anchor --> </a> <h5 class="section-title" id="d9338807e300">RESULTS</h5> <p id="P15">Of 1179 patients with sepsis reported at 54 hospitals (mean [SD] age, 7.2 [6.2] years; male, 54.2%; previously healthy, 44.5%; diagnosed as having shock, 68.8%), 139 (11.8%) died. The entire sepsis bundle was completed in 1 hour in 294 patients (24.9%). Antibiotics were administered to 798 patients (67.7%), blood cultures were obtained in 740 patients (62.8%), and the fluid bolus was completed in 548 patients (46.5%) within 1 hour. </p> <p id="P16">Completion of the entire bundle within 1 hour was associated with lower risk-adjusted odds of in-hospital mortality (odds ratio [OR], 0.59 [95% CI, 0.38 to 0.93], <i>P</i> = .02; predicted risk difference [RD], 4.0% [95% CI, 0.9% to 7.0%]). However, completion of each individual bundle element within 1 hour was not significantly associated with lower risk-adjusted mortality (blood culture: OR, 0.73 [95% CI, 0.51 to 1.06], <i>P</i> = .10; RD, 2.6% [95% CI, −0.5% to 5.7%]; antibiotics: OR, 0.78 [95% CI, 0.55 to 1.12], <i>P</i> = .18; RD, 2.1% [95% CI, −1.1% to 5.2%], and fluid bolus: OR, 0.88 [95% CI, 0.56 to 1.37], <i>P</i> = .56; RD, 1.1% [95% CI, −2.6% to 4.8%]). </p> </div><div class="section"> <a class="named-anchor" id="S7"> <!-- named anchor --> </a> <h5 class="section-title" id="d9338807e319">CONCLUSIONS AND RELEVANCE</h5> <p id="P17">In New York State following a mandate for sepsis care, completion of a sepsis bundle within 1 hour compared with not completing the 1-hour sepsis bundle within 1 hour was associated with lower risk-adjusted in-hospital mortality among patients with pediatric sepsis and septic shock. </p> </div>

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          Most cited references12

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          Time to Treatment and Mortality during Mandated Emergency Care for Sepsis.

          Background In 2013, New York began requiring hospitals to follow protocols for the early identification and treatment of sepsis. However, there is controversy about whether more rapid treatment of sepsis improves outcomes in patients. Methods We studied data from patients with sepsis and septic shock that were reported to the New York State Department of Health from April 1, 2014, to June 30, 2016. Patients had a sepsis protocol initiated within 6 hours after arrival in the emergency department and had all items in a 3-hour bundle of care for patients with sepsis (i.e., blood cultures, broad-spectrum antibiotic agents, and lactate measurement) completed within 12 hours. Multilevel models were used to assess the associations between the time until completion of the 3-hour bundle and risk-adjusted mortality. We also examined the times to the administration of antibiotics and to the completion of an initial bolus of intravenous fluid. Results Among 49,331 patients at 149 hospitals, 40,696 (82.5%) had the 3-hour bundle completed within 3 hours. The median time to completion of the 3-hour bundle was 1.30 hours (interquartile range, 0.65 to 2.35), the median time to the administration of antibiotics was 0.95 hours (interquartile range, 0.35 to 1.95), and the median time to completion of the fluid bolus was 2.56 hours (interquartile range, 1.33 to 4.20). Among patients who had the 3-hour bundle completed within 12 hours, a longer time to the completion of the bundle was associated with higher risk-adjusted in-hospital mortality (odds ratio, 1.04 per hour; 95% confidence interval [CI], 1.02 to 1.05; P<0.001), as was a longer time to the administration of antibiotics (odds ratio, 1.04 per hour; 95% CI, 1.03 to 1.06; P<0.001) but not a longer time to the completion of a bolus of intravenous fluids (odds ratio, 1.01 per hour; 95% CI, 0.99 to 1.02; P=0.21). Conclusions More rapid completion of a 3-hour bundle of sepsis care and rapid administration of antibiotics, but not rapid completion of an initial bolus of intravenous fluids, were associated with lower risk-adjusted in-hospital mortality. (Funded by the National Institutes of Health and others.).
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            Applying Quantitative Bias Analysis to Epidemiologic Data

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              Implementation of goal-directed therapy for children with suspected sepsis in the emergency department.

              Suboptimal care for children with septic shock includes delayed recognition and inadequate fluid resuscitation. To describe the implementation of an emergency department (ED) protocol for the recognition of septic shock and facilitate adherence to national treatment guidelines. Root-cause analyses and morbidity and mortality conferences identified system problems with sepsis recognition and management. A group of ED and critical care physicians met to identify barriers and create solutions. To facilitate sepsis recognition, a computerized triage system alarmed on abnormal vital signs, and then toxic-appearing children or children at high risk for invasive infection were placed in a resuscitation room. To facilitate timely delivery of interventions, additional nursing, respiratory therapy, and pharmacy personnel were recruited. Fluids were administered via syringe delivery; standardized laboratory studies and antibiotics were ordered and prioritized. Frequent vital-sign measurements and interventions were documented on a graphical flow sheet to facilitate interpretation of physiologic response to therapy. After protocol initiation, there were 191 encounters in 167 patients with suspected sepsis. When compared with children seen before the protocol, time from triage to first bolus decreased from a median of 56 to 22 minutes (P < .001) and triage to first antibiotics decreased from a median of 130 to 38 minutes (P < .001). The protocol resulted in earlier recognition of suspected sepsis and substantial reductions in both time to receipt of time-sensitive interventions and a decrement in treatment variation.
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                Author and article information

                Journal
                JAMA
                JAMA
                American Medical Association (AMA)
                0098-7484
                July 24 2018
                July 24 2018
                : 320
                : 4
                : 358
                Affiliations
                [1 ]Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
                [2 ]The Clinical Research, Investigation, and Systems Modeling of Acute Illness (CRISMA) Center, Pittsburgh, Pennsylvania
                [3 ]IPRO, Lake Success, New York
                [4 ]Division of Emergency Medicine, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois
                [5 ]Associate Editor, JAMA, Chicago, Illinois
                [6 ]New York State Department of Health, Albany
                [7 ]Department of Pediatrics, Division of Critical Care, BC Children’s Hospital and Research Institute, University of British Columbia, Vancouver, British Columbia, Canada
                [8 ]Division of Biostatistics, College of Public Health, The Ohio State University, Columbus
                [9 ]Department of Medicine, Division of Pulmonary Critical Care & Sleep, Alpert Medical School of Brown University, Providence, Rhode Island
                [10 ]Department of Pediatrics, Pediatric Critical Care Medicine, Stony Brook Children’s Hospital, Stony Brook, New York
                [11 ]Pediatric Critical Care Medicine, Seattle Children’s Hospital and Research Institute, Seattle, Washington
                [12 ]Division of Critical Care Medicine, Department of Anesthesiology and Critical Care, The Children’s Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia
                Article
                10.1001/jama.2018.9071
                6500448
                30043064
                494b47ff-5ae5-4e98-8f57-b166ae896042
                © 2018
                History

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