Dataset Information

Assessment of a Cellular Host Response Test as a Sepsis Diagnostic for Those With Suspected Infection in the Emergency Department.

ABSTRACT:

Objectives

Sepsis is a common cause of morbidity and mortality. A reliable, rapid, and early indicator can help improve efficiency of care and outcomes. To assess the IntelliSep test, a novel in vitro diagnostic that quantifies the state of immune activation by measuring the biophysical properties of leukocytes, as a rapid diagnostic for sepsis and a measure of severity of illness, as defined by Sequential Organ Failure Assessment and Acute Physiology and Chronic Health Evaluation-II scores and the need for hospitalization.

Design setting subjects

Adult patients presenting to two emergency departments in Baton Rouge, LA, with signs of infection (two of four systemic inflammatory response syndrome criteria, with at least one being aberration of temperature or WBC count) or suspicion of infection (a clinician order for culture of a body fluid), were prospectively enrolled. Sepsis status, per Sepsis-3 criteria, was determined through a 3-tiered retrospective and blinded adjudication process consisting of objective review, site-level clinician review, and final determination by independent physician adjudicators.

Measurements and main results

Of 266 patients in the final analysis, those with sepsis had higher IntelliSep Index (median = 6.9; interquartile range, 6.1-7.6) than those adjudicated as not septic (median = 4.7; interquartile range, 3.7-5.9; p < 0.001), with an area under the receiver operating characteristic curve of 0.89 and 0.83 when compared with unanimous and forced adjudication standards, respectively. Patients with higher IntelliSep Index had higher Sequential Organ Failure Assessment (3 [interquartile range, 1-5] vs 1 [interquartile range, 0-2]; p < 0.001) and Acute Physiology and Chronic Health Evaluation-II (7 [interquartile range, 3.5-11.5] vs 5 [interquartile range, 2-9]; p < 0.05) and were more likely to be admitted to the hospital (83.6% vs 48.3%; p < 0.001) compared with those with lower IntelliSep Index.

Conclusions

In patients presenting to the emergency department with signs or suspicion of infection, the IntelliSep Index is a promising tool for the rapid diagnosis and risk stratification for sepsis.

SUBMITTER: O'Neal HR

PROVIDER: S-EPMC8208428 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:PURPOSE:Sepsis is a common acute life-threatening condition that emergency physicians routinely face. Diagnostic options within the Emergency Department (ED) are limited due to lack of infrastructure, consequently limiting the use of invasive hemodynamic monitoring or imaging tests. The mortality rate due to sepsis can be assessed via multiple scoring systems, for example, mortality in emergency department sepsis (MEDS) score and sepsis patient evaluation in the emergency department (SPEED) score, both of which quantify the variation of mortality rates according to clinical findings, laboratory data, or therapeutic interventions. This study aims to improve the management processes of sepsis patients by comparing SPEED score and MEDS score for predicting the 28-day mortality in cases of emergency sepsis. METHODS:The study is a cross-sectional, prospective study including 61 sepsis patients in ED in Suez Canal University Hospital, Egypt, from August 2017 to June 2018. Patients were selected by two steps: (1) suspected septic patients presenting with at least one of the following abnormal clinical findings: (a) body temperature higher than 38 °C or lower than 36 °C, (b) heart rate higher than 90 beats/min, (c) hyperventilation evidenced by respiratory rate higher than 20 breaths/min or PaCO2 lower than 32 mmHg, and (d) white blood cell count higher than 12,000/?L or lower than 4000/?L; (2) confirmed septic patients with at least a 2-point increase from the baseline total sequential organ failure assessment (SOFA) score following infection. Other inclusion criteria included adult patients with an age ?18 years regardless of gender and those who had either systemic inflammatory response syndrome or suspected/confirmed infection. Patients were shortly follow-up for the 28-day mortality. Each patient was subject to SPEED score and MEDS score and then the results were compared to detect which of them was more effective in predicting outcome. The receiver operating characteristic curves were also done for MEDS and SPEED scores. RESULTS:Among the 61 patients, 41 died with the mortality rate of 67.2%. The mortality rate increased with a higher SPEED and MEDS scores. Both SPEED and MEDS scores revealed significant difference between the survivors and nonsurvivors (p = 0.004 and p < 0.001, respectively), indicating that both the two systems are effective in predicting the 28-day mortality of sepsis patients. Thereafter, the receiver operating characteristic curves were plotted, which showed that SPEED was better than the MEDS score when applied to the complete study population with an area under the curve being 0.87 (0.788-0.963) as compared with 0.75 (0.634-0.876) for MEDS. Logistic regression analysis revealed that the best fitting predictor of 28-day mortality for sepsis patients was the SPEED scoring system. For every one unit increase in SPEED score, the odds of 28-day mortality increased by 37%. CONCLUSION:SPEED score is more useful and accurate than MEDS score in predicting the 28-day mortality among sepsis patients. Therefore SPEED rather than MEDS should be more widely used in the ED for sepsis patients.

Project description:OBJECTIVE:To derive and validate a new clinical prediction rule to risk-stratify emergency department (ED) patients admitted with suspected sepsis. DESIGN:Retrospective prognostic study of prospectively collected data. SETTING:ED. PARTICIPANTS:Patients aged ?18 years who met two Systemic Inflammatory Response Syndrome criteria or one Red Flag sepsis criteria on arrival, received intravenous antibiotics for a suspected infection and admitted. PRIMARY OUTCOME MEASURE:In-hospital all-cause mortality. METHOD:The data were divided into derivation and validation cohorts. The simplified-Mortality in Severe Sepsis in the ED score and quick-SOFA scores, refractory hypotension and lactate were collectively termed 'component scores' and cumulatively termed the 'Risk-stratification of ED suspected Sepsis (REDS) score'. Each patient in the derivation cohort received a score (0-3) for each component score. The REDS score ranged from 0 to 12. The component scores were subject to univariate and multivariate logistic regression analyses. The receiver operator characteristic (ROC) curves for the REDS and the components scores were constructed and their cut-off points identified. Scores above the cut-off points were deemed high-risk. The area under the ROC (AUROC) curves and sensitivity for mortality of the high-risk category of the REDS score and component scores were compared. The REDS score was internally validated. RESULTS:2115 patients of whom 282 (13.3%) died in hospital. Derivation cohort: 1078 patients with 140 deaths (13%). The AUROC curve with 95% CI, cut-off point and sensitivity for mortality (95% CI) of the high-risk category of the REDS score were: derivation: 0.78 (0.75 to 0.80); ?3; 85.0 (78 to 90.5). VALIDATION:0.74 (0.71 to 0.76); ?3; 84.5 (77.5 to 90.0). The AUROC curve and the sensitivity for mortality of the REDS score was better than that of the component scores. Specificity and mortality rates for REDS scores of ?3, ?5 and ?7 were 54.8%, 88.8% and 96.9% and 21.8%, 36.0% and 49.1%, respectively. CONCLUSION:The REDS score is a simple and objective score to risk-stratify ED patients with suspected sepsis.