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OBJECTIVES: To describe the Children's Hospital Association's Improving Pediatric Sepsis Outcomes sepsis definitions and the identified patients; evaluate the definition using a published framework for evaluating sepsis definitions. DESIGN: Observational cohort. SETTING: Multicenter quality improvement collaborative of 46 hospitals from January 2017 to December 2018, excluding neonatal ICUs. PATIENTS: Improving Pediatric Sepsis Outcomes Sepsis was defined by electronic health record evidence of suspected infection and sepsis treatment or organ dysfunction. A more severely ill subgroup, Improving Pediatric Sepsis Outcomes Critical Sepsis, was defined, approximating septic shock. INTERVENTIONS: Participating hospitals identified patients, extracted data, and transferred de-identified data to a central data warehouse. The definitions were evaluated across domains of reliability, content validity, construct validity, criterion validity, measurement burden, and timeliness. MEASUREMENTS AND MAIN RESULTS: Forty hospitals met data quality criteria across four electronic health record platforms. There were 23,976 cases of Improving Pediatric Sepsis Outcomes Sepsis, including 8,565 with Improving Pediatric Sepsis Outcomes Critical Sepsis. The median age was 5.9 years. There were 10,316 (43.0%) immunosuppressed or immunocompromised patients, 4,135 (20.3%) with central lines, and 2,352 (11.6%) chronically ventilated. Among Improving Pediatric Sepsis Outcomes Sepsis patients, 60.8% were admitted to intensive care, 26.4% had new positive-pressure ventilation, and 19.7% received vasopressors. Median hospital length of stay was 6.0 days (3.0-13.0 d). All-cause 30-day in-hospital mortality was 958 (4.0%) in Improving Pediatric Sepsis Outcomes Sepsis; 541 (6.3%) in Improving Pediatric Sepsis Outcomes Critical Sepsis. The Improving Pediatric Sepsis Outcomes Sepsis definitions demonstrated strengths in content validity, convergent construct validity, and criterion validity; weakness in reliability. Improving Pediatric Sepsis Outcomes Sepsis definitions had significant initial measurement burden (median time from case completion to submission: 15 mo [interquartile range, 13-18 mo]); timeliness improved once data capture was established (median, 26 d; interquartile range, 23-56 d). CONCLUSIONS: The Improving Pediatric Sepsis Outcomes Sepsis definitions demonstrated feasibility for large-scale data abstraction. The patients identified provide important information about children treated for sepsis. When operationalized, these definitions enabled multicenter identification and data aggregation, indicating practical utility for quality improvement.

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OBJECTIVE: To evaluate the impact of early disseminated intravascular coagulation (DIC) on illness severity in children using a database of emergency department ED encounters for children with suspected sepsis, in view of similar associations in adults. STUDY DESIGN: Laboratory and clinical data were extracted from a registry of emergency department encounters of children with suspected sepsis between April 1, 2012, and June 26, 2017. International Society of Thrombosis and Hemostasis DIC scores were calculated from laboratory values obtained within 24 hours of emergency department admission. Univariate logistic regression, multivariable logistic regression, and Cox regression were used to assess the influence of DIC scores on vasopressor use (primary outcome), mortality, ventilator requirement, pediatric intensive care unit admission, and hospital duration (secondary outcomes). The optimal DIC score cutoff for outcome prediction was determined. RESULTS: Of 1653 eligible patients, 284 had DIC scores within 24 hours, including 92 who required vasopressors and 23 who died within 1 year. An initial DIC score of ≥3 was the most sensitive and specific DIC score for predicting adverse outcomes. Those with a DIC score of ≥3 vs <3 had increased odds of vasopressor use in both univariate (OR, 4.48; 95% CI, 2.63-7.62; P < .001) and multivariable (OR, 3.78; 95% CI, 1.82-7.85; P < .001) analyses. Additionally, those with a DIC score of ≥3 vs <3 had increased 1-year mortality with a hazard ratio of 3.55 (95% CI, 1.46-8.64; P = .005). CONCLUSIONS: A DIC score of ≥3 was an independent predictor for both vasopressor use and mortality in this pediatric cohort, distinct from the adult overt DIC score cutoff of ≥5.

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OBJECTIVES: To develop evidence-based recommendations for clinicians caring for children (including infants, school-aged children, and adolescents) with septic shock and other sepsis-associated organ dysfunction. DESIGN: A panel of 49 international experts, representing 12 international organizations, as well as three methodologists and three public members was convened. Panel members assembled at key international meetings (for those panel members attending the conference), and a stand-alone meeting was held for all panel members in November 2018. A formal conflict-of-interest policy was developed at the onset of the process and enforced throughout. Teleconferences and electronic-based discussion among the chairs, co-chairs, methodologists, and group heads, as well as within subgroups, served as an integral part of the guideline development process. METHODS: The panel consisted of six subgroups: recognition and management of infection, hemodynamics and resuscitation, ventilation, endocrine and metabolic therapies, adjunctive therapies, and research priorities. We conducted a systematic review for each Population, Intervention, Control, and Outcomes question to identify the best available evidence, statistically summarized the evidence, and then assessed the quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. We used the evidence-to-decision framework to formulate recommendations as strong or weak, or as a best practice statement. In addition, "in our practice" statements were included when evidence was inconclusive to issue a recommendation, but the panel felt that some guidance based on practice patterns may be appropriate. RESULTS: The panel provided 77 statements on the management and resuscitation of children with septic shock and other sepsis-associated organ dysfunction. Overall, six were strong recommendations, 52 were weak recommendations, and nine were best-practice statements. For 13 questions, no recommendations could be made; but, for 10 of these, "in our practice" statements were provided. In addition, 49 research priorities were identified. CONCLUSIONS: A large cohort of international experts was able to achieve consensus regarding many recommendations for the best care of children with sepsis, acknowledging that most aspects of care had relatively low quality of evidence resulting in the frequent issuance of weak recommendations. Despite this challenge, these recommendations regarding the management of children with septic shock and other sepsis-associated organ dysfunction provide a foundation for consistent care to improve outcomes and inform future research.

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OBJECTIVE: To derive and validate a model of risk of septic shock among children with suspected sepsis, using data known in the electronic health record at hospital arrival. STUDY DESIGN: This observational cohort study at 6 pediatric emergency department and urgent care sites used a training dataset (5 sites, April 1, 2013, to December 31, 2016), a temporal test set (5 sites, January 1, 2017 to June 30, 2018), and a geographic test set (a sixth site, April 1, 2013, to December 31, 2018). Patients 60 days to 18 years of age in whom clinicians suspected sepsis were included; patients with septic shock on arrival were excluded. The outcome, septic shock, was systolic hypotension with vasoactive medication or ≥30 mL/kg of isotonic crystalloid within 24 hours of arrival. Elastic net regularization, a penalized regression technique, was used to develop a model in the training set. RESULTS: Of 2464 included visits, septic shock occurred in 282 (11.4%). The model had an area under the curve of 0.79 (0.76-0.83) in the training set, 0.75 (0.69-0.81) in the temporal test set, and 0.87 (0.73-1.00) in the geographic test set. With a threshold set to 90% sensitivity in the training set, the model yielded 82% (72%-90%) sensitivity and 48% (44%-52%) specificity in the temporal test set, and 90% (55%-100%) sensitivity and 32% (21%-46%) specificity in the geographic test set. CONCLUSIONS: This model estimated the risk of septic shock in children at hospital arrival earlier than existing models. It leveraged the predictive value of routine electronic health record data through a modern predictive algorithm and has the potential to enhance clinical risk stratification in the critical moments before deterioration.

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OBJECTIVES: To assess whether the risk of missed clinician diagnosis of pediatric sepsis requiring care in the intensive care unit (ICU) was greater in community vs tertiary pediatric emergency care settings with sepsis pathways. STUDY DESIGN: An observational cohort study in a tertiary pediatric emergency department (ED) staffed by pediatric emergency physicians and 4 affiliated community pediatric ED/urgent care sites staffed by general pediatricians. Use of an institutional sepsis order set or pathway was considered clinician diagnosis of sepsis. Risk of missed diagnosis was compared for 2 outcomes: suspected infection plus ICU admission (sepsis-ICU) and suspected infection plus vasoactive agent/positive-pressure ventilation (sepsis-VV). RESULTS: From January 1, 2014 to December 31, 2015, there were 141 552 tertiary and 139 332 community emergency visits. Clinicians diagnosed sepsis in 1136 visits; median age was 5.7 (2.4, 12.0) years. In the tertiary ED, there were 306 sepsis-ICU visits (0.2%) and 112 sepsis-VV visits (0.08%). In community sites, there were 46 sepsis-ICU visits (0.03%) and 20 sepsis-VV visits (0.01%). The risk of missed diagnosis in community vs tertiary sites was significantly greater for sepsis-ICU (relative risk 4.30, CI 2.15-8.60) and sepsis-VV (relative risk 14.0, CI 2.91-67.24). Sensitivity for sepsis-ICU was 94.4% (91.3%-96.5%) at the tertiary site and 76.1% (62.1%-86.1%) at community sites. CONCLUSIONS: The risk of missed diagnosis of sepsis-ICU was greater in community vs tertiary emergency care settings despite shared pathways and education, but with differences in resources, providers, and sepsis incidence. More research is needed to optimize diagnostic approaches in all settings.

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OBJECTIVES: Intubation in critically ill pediatric patients is associated with approximately 20% rate of adverse events, but rates in the high-risk condition of sepsis are unknown. Our objectives were to describe the frequency and characteristics of tracheal intubation adverse events in pediatric sepsis. DESIGN: Retrospective cohort study of a sepsis registry. SETTING: Two tertiary care academic emergency departments and four affiliated urgent cares within a single children's hospital health system. PATIENTS: Children 60 days and older to 18 years and younger who required nonelective intubation within 24 hours of emergency department arrival. Exclusion criteria included elective intubation, intubation prior to emergency department arrival, presence of tracheostomy, or missing intubation chart data. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: The outcome was tracheal intubation adverse event as defined by the National Emergency Airway Registry Tool 4 KIDS. During the study period, 118 of 2,395 registry patients met inclusion criteria; 100% of intubations were successful. First attempt success rate was 57% (95% CI, 48-65%); 59% were intubated in the emergency department, and 28% were intubated in the PICU. First attempts were by a resident (30%), a fellow (42%), attending (6%), and anesthesiologist (13%). Tracheal intubation adverse events were reported in 61 (43%; 95% 43-61%) intubations with severe tracheal intubation adverse events in 22 (17%; 95 CI, 13-27%) intubations. Hypotension was the most common severe event (n = 20 [17%]) with 14 novel occurrences during intubation. Mainstem bronchial intubation was the most common nonsevere event (n = 28 [24%]). Residents, advanced practice providers, and general pediatricians in urgent care settings had the lowest rates of first-pass success. CONCLUSIONS: The rates of tracheal intubation adverse events in this study are higher than in nonelective pediatric intubations in all conditions and highlight the high-risk nature of intubations in pediatric sepsis. Further research is needed to identify optimal practices for intubation in pediatric sepsis.

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OBJECTIVES: To assess the validity of Vasoactive-Inotropic Score as a scoring system for cardiovascular support and surrogate outcome in pediatric sepsis. DESIGN: Secondary retrospective analysis of a single-center sepsis registry. SETTING: Freestanding children's hospital and tertiary referral center. PATIENTS: Children greater than 60 days and less than 18 years with sepsis identified in the emergency department between January 2012 and June 2015 treated with at least one vasoactive medication within 48 hours of admission to the PICU. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Vasoactive-Inotropic Score was abstracted at 6, 12, 24, and 48 hours post ICU admission. Primary outcomes were ventilator days and ICU length of stay. The secondary outcome was a composite outcome of cardiac arrest/extracorporeal membrane oxygenation/in-hospital mortality. One hundred thirty-eight patients met inclusion criteria. Most common infectious sources were pneumonia (32%) and bacteremia (23%). Thirty-three percent were intubated and mortality was 6%. Of the time points assessed, Vasoactive-Inotropic Score at 48 hours showed the strongest correlation with ICU length of stay (r = 0.53; p < 0.0001) and ventilator days (r = 0.52; p < 0.0001). On multivariable analysis, Vasoactive-Inotropic Score at 48 hours was a strong independent predictor of primary outcomes and intubation. For every unit increase in Vasoactive-Inotropic Score at 48 hours, there was a 13% increase in ICU length of stay (p < 0.001) and 8% increase in ventilator days (p < 0.01). For every unit increase in Vasoactive-Inotropic Score at 12 hours, there was a 14% increase in odds of having the composite outcome (p < 0.01). CONCLUSIONS: Vasoactive-Inotropic Score in pediatric sepsis patients is independently associated with important clinically relevant outcomes including ICU length of stay, ventilator days, and cardiac arrest/extracorporeal membrane oxygenation/mortality. Vasoactive-Inotropic Score may be a useful surrogate outcome in pediatric sepsis.

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OBJECTIVES: To evaluate whether lactate clearance and normalization during emergency care of pediatric sepsis is associated with lower rates of persistent organ dysfunction. STUDY DESIGN: This was a prospective cohort study of 77 children <18 years of age in the emergency department with infection and acute organ dysfunction per consensus definitions. In consented patients, lactate was measured 2 and/or 4 hours after an initial lactate; persistent organ dysfunction was assessed through laboratory and physician evaluation at 48 hours. A decrease of ≥ 10% from initial to final level was considered lactate clearance; a final level < 2 mmol/L was considered lactate normalization. Relative risk (RR) with 95% CIs, adjusted in a log-binomial model, was used to evaluate associations between lactate clearance/normalization and organ dysfunction. RESULTS: Lactate normalized in 62 (81%) patients and cleared in 70 (91%). The primary outcome, persistent 48-hour organ dysfunction, was present in 32 (42%). Lactate normalization was associated with decreased risk of persistent organ dysfunction (RR 0.46, 0.29-0.73; adjusted RR 0.47, 0.29-0.78); lactate clearance was not (RR 0.70, 0.35-1.41; adjusted RR 0.75, 0.38-1.50). The association between lactate normalization and decreased risk of persistent organ dysfunction was retained in the subgroups with initial lactate ≥ 2 mmol/L and hypotension. CONCLUSIONS: In children with sepsis and organ dysfunction, lactate normalization within 4 hours was associated with decreased persistent organ dysfunction. Serial lactate level measurement may provide a useful prognostic tool during the first hours of resuscitation in pediatric sepsis.

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OBJECTIVES: To evaluate accuracy of 2 established administrative methods of identifying children with sepsis using a medical record review reference standard. STUDY DESIGN: Multicenter retrospective study at 6 US children's hospitals. Subjects were children >60 days to <19 years of age and identified in 4 groups based on International Classification of Diseases, Ninth Revision, Clinical Modification codes: (1) severe sepsis/septic shock (sepsis codes); (2) infection plus organ dysfunction (combination codes); (3) subjects without codes for infection, organ dysfunction, or severe sepsis; and (4) infection but not severe sepsis or organ dysfunction. Combination codes were allowed, but not required within the sepsis codes group. We determined the presence of reference standard severe sepsis according to consensus criteria. Logistic regression was performed to determine whether addition of codes for sepsis therapies improved case identification. RESULTS: A total of 130 out of 432 subjects met reference SD of severe sepsis. Sepsis codes had sensitivity 73% (95% CI 70-86), specificity 92% (95% CI 87-95), and positive predictive value 79% (95% CI 70-86). Combination codes had sensitivity 15% (95% CI 9-22), specificity 71% (95% CI 65-76), and positive predictive value 18% (95% CI 11-27). Slight improvements in model characteristics were observed when codes for vasoactive medications and endotracheal intubation were added to sepsis codes (c-statistic 0.83 vs 0.87, P = .008). CONCLUSIONS: Sepsis specific International Classification of Diseases, Ninth Revision, Clinical Modification codes identify pediatric patients with severe sepsis in administrative data more accurately than a combination of codes for infection plus organ dysfunction.

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OBJECTIVES: This study sought to determine the prevalence, test characteristics, and severity of illness of pediatric patients with systemic inflammatory response syndrome (SIRS) vital signs among pediatric emergency department (ED) visits. METHODS: This was a retrospective descriptive cohort study of all visits to the ED of a tertiary academic free-standing pediatric hospital over 1 year. Visits were included if the patient was <18 years of age and did not leave before full evaluation or against medical advice. Exclusion criteria were trauma diagnoses or missing documentation of vital signs. Data were electronically extracted from the medical record. The primary predictor was presence of vital signs meeting pediatric SIRS definitions. Specific vital sign pairs comprising SIRS were evaluated as predictors (temperature-heart rate, temperature-respiratory rate, and temperature-corrected heart rate, in which a formula was used to correct heart rate for degree of temperature elevation). The primary outcome measure was requirement for critical care (receipt of a vasoactive agent or intubation) within 24 hours of ED arrival. RESULTS: There were 56,210 visits during the study period; 40,356 met inclusion criteria. Of these, 6,596 (16.3%) visits had fever >38.5°C, and 6,122 (15.2% of included visits) met SIRS vital sign criteria. Among included visits, those with SIRS vital signs accounted for 92.8% of all visits with fever >38.5°C. Among patients with SIRS vital signs, 4993 (81.6%) were discharged from the ED without intravenous (IV) therapy and without 72-hour readmission. Critical care within the first 24 hours was present in 99 (0.25%) patients: 23 patients with and 76 without SIRS vital signs. Intensive care unit (ICU) admission was present in 126 (2.06%) with SIRS vital signs and 487 (1.42%) without SIRS vital signs. SIRS vital signs were associated with increased risk of critical care within 24 hours (relative risk [RR] = 1.69, 95% confidence interval [CI] = 1.06 to 2.70), ICU admission (RR = 1.45, 95% CI = 1.19 to 1.76), ED laboratory tests (RR = 1.41, 95% CI = 1.37 to 1.45), ED IV medication/fluid administration (RR = 2.54, 95% CI = 2.29 to 2.82), hospital admission (RR = 1.52, 95% CI = 1.42 to 1.63), and 72-hour readmission (RR = 1.31, 95% CI = 1.01 to 1.69). SIRS vital signs were not associated with 30-day in-hospital mortality (RR = 0.37, 95% CI = 0.05 to 2.82). SIRS vital signs had a low sensitivity for critical care requirement (23.2%, 95% CI = 15.3% to 32.8%). The pair of SIRS vital signs with the strongest association with critical care requirement was temperature and corrected heart rate (positive likelihood ratio = 2.74, 95% CI = 1.87 to 4.01). CONCLUSIONS: Systemic inflammatory response syndrome vital signs are common among medical pediatric patients presenting to an ED, and critical illness is rare. The majority of patients with SIRS vital signs were discharged without IV therapy and without readmission. Patients with SIRS vital signs had a statistically significant increased risk of critical care requirement, ED IV treatment, ED laboratory tests, admission, and readmission. However, SIRS vital sign criteria did not identify the majority of patients with mortality or need for critical care. SIRS vital signs had low sensitivity for critical illness, making it poorly suited for use in isolation in this setting as a test to detect children requiring sepsis resuscitation.

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Gram-positive organisms are the most common infectious etiologic agents in skin abscesses. Empiric antimicrobial treatment choices are influenced by this knowledge. In this report, we describe a high prevalence of Proteus mirabilis, a Gram-negative bacillus, in skin abscesses of the axilla, which has potential implications for selection of antimicrobial therapy.

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