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Effectiveness of corticosteroids in patients with sepsis or septic shock using the new third international consensus definitions (Sepsis-3): A retrospective observational study.

ABSTRACT: Background: The effects of intravenous corticosteroids in patients with sepsis remain controversial due to mixed results from randomized trials. Moreover, updated definitions of sepsis, Sepsis-3, were proposed in 2016, and findings related to the effects of corticosteroids in patients defined by the Sepsis-3 criteria are scarce.

Objective: To investigate the effectiveness of corticosteroids in patients with sepsis or septic shock using real-world data to complement the findings of randomized controlled trials, and to determine whether the treatment effects differ by sepsis definitions.

Methods: We conducted this study by utilizing a large, multi-center healthcare database, eICU, in which we identified patients with sepsis admitted to 208 intensive care units across the US from 2014 to 2015 based on two different definitions: prior explicit definitions (i.e., based on diagnosis codes) and the Sepsis-3 definitions (i.e., based on SOFA score). The association between intravenous corticosteroids and in-hospital survival up to 50 days in patients with sepsis was retrospectively analyzed. A parametric hazard model with stabilized inverse probability of treatment weight adjustment was used to control for baseline confounders.

Results: Of the 7,158 patients identified based on the explicit definition, 562 (7.9%) received corticosteroids; of the 5,009 patients identified based on the Sepsis-3 definition, 465 (9.3%) received corticosteroids. In the explicit cohort, adjusted in-hospital survival at day 50 was 0.62 in the treated vs 0.57 in the non-treated, with a survival difference of 0.05 (95%CI: -0.11, 0.17). Similar results were seen in the Sepsis-3 cohort (0.58 vs 0.56 in treated and non-treated, respectively), with a 50-day survival difference of 0.02 (95%CI: -0.19, 0.17).

Conclusions: In patients with sepsis or septic shock, intravenous corticosteroids were not associated with a higher in-hospital survival up to 50 days regardless of the sepsis definitions. Further research may be necessary to definitively confirm effectiveness in real-world practice.

SUBMITTER: Wu YP

PROVIDER: S-EPMC7714118 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Effectiveness of corticosteroids in patients with sepsis or septic shock using the new third international consensus definitions (Sepsis-3): A retrospective observational study.

Wu Yu-Pu YP Lauffenburger Julie C JC

PloS one 20201203 12

<h4>Background</h4>The effects of intravenous corticosteroids in patients with sepsis remain controversial due to mixed results from randomized trials. Moreover, updated definitions of sepsis, Sepsis-3, were proposed in 2016, and findings related to the effects of corticosteroids in patients defined by the Sepsis-3 criteria are scarce.<h4>Objective</h4>To investigate the effectiveness of corticosteroids in patients with sepsis or septic shock using real-world data to complement the findings of r ...[more]

PMID: 33270762

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Project description:IMPORTANCE:The Third International Consensus Definitions Task Force defined sepsis as "life-threatening organ dysfunction due to a dysregulated host response to infection." The performance of clinical criteria for this sepsis definition is unknown. OBJECTIVE:To evaluate the validity of clinical criteria to identify patients with suspected infection who are at risk of sepsis. DESIGN, SETTINGS, AND POPULATION:Among 1.3 million electronic health record encounters from January 1, 2010, to December 31, 2012, at 12 hospitals in southwestern Pennsylvania, we identified those with suspected infection in whom to compare criteria. Confirmatory analyses were performed in 4 data sets of 706,399 out-of-hospital and hospital encounters at 165 US and non-US hospitals ranging from January 1, 2008, until December 31, 2013. EXPOSURES:Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score, systemic inflammatory response syndrome (SIRS) criteria, Logistic Organ Dysfunction System (LODS) score, and a new model derived using multivariable logistic regression in a split sample, the quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) score (range, 0-3 points, with 1 point each for systolic hypotension [?100 mm Hg], tachypnea [?22/min], or altered mentation). MAIN OUTCOMES AND MEASURES:For construct validity, pairwise agreement was assessed. For predictive validity, the discrimination for outcomes (primary: in-hospital mortality; secondary: in-hospital mortality or intensive care unit [ICU] length of stay ?3 days) more common in sepsis than uncomplicated infection was determined. Results were expressed as the fold change in outcome over deciles of baseline risk of death and area under the receiver operating characteristic curve (AUROC). RESULTS:In the primary cohort, 148,907 encounters had suspected infection (n?=?74,453 derivation; n?=?74,454 validation), of whom 6347 (4%) died. Among ICU encounters in the validation cohort (n?=?7932 with suspected infection, of whom 1289 [16%] died), the predictive validity for in-hospital mortality was lower for SIRS (AUROC?=?0.64; 95% CI, 0.62-0.66) and qSOFA (AUROC?=?0.66; 95% CI, 0.64-0.68) vs SOFA (AUROC?=?0.74; 95% CI, 0.73-0.76; P?<?.001 for both) or LODS (AUROC?=?0.75; 95% CI, 0.73-0.76; P?<?.001 for both). Among non-ICU encounters in the validation cohort (n?=?66?522 with suspected infection, of whom 1886 [3%] died), qSOFA had predictive validity (AUROC?=?0.81; 95% CI, 0.80-0.82) that was greater than SOFA (AUROC?=?0.79; 95% CI, 0.78-0.80; P?<?.001) and SIRS (AUROC?=?0.76; 95% CI, 0.75-0.77; P?<?.001). Relative to qSOFA scores lower than 2, encounters with qSOFA scores of 2 or higher had a 3- to 14-fold increase in hospital mortality across baseline risk deciles. Findings were similar in external data sets and for the secondary outcome. CONCLUSIONS AND RELEVANCE:Among ICU encounters with suspected infection, the predictive validity for in-hospital mortality of SOFA was not significantly different than the more complex LODS but was statistically greater than SIRS and qSOFA, supporting its use in clinical criteria for sepsis. Among encounters with suspected infection outside of the ICU, the predictive validity for in-hospital mortality of qSOFA was statistically greater than SOFA and SIRS, supporting its use as a prompt to consider possible sepsis.

Project description:The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) present clinical criteria for the classification of patients with sepsis. We investigated incidence and long-term outcomes of patients diagnosed with these classifications, which are currently unknown.We did a retrospective analysis using data from 30?239 participants from the USA who were aged at least 45 years and enrolled in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) cohort. Patients were enrolled between Jan 25, 2003, and Oct 30, 2007, and we identified hospital admissions from Feb 5, 2003, to Dec 31, 2012, and applied three classifications: infection and systemic inflammatory response syndrome (SIRS) criteria, elevated sepsis-related organ failure assessment (SOFA) score from Sepsis-3, and elevated quick SOFA (qSOFA) score from Sepsis-3. We estimated incidence during the study period, in-hospital mortality, and 1-year mortality.Of 2593 first infection events, 1526 met SIRS criteria, 1080 met SOFA criteria, and 378 met qSOFA criteria. Incidence was 8·2 events (95% CI 7·8-8·7) per 1000 person-years for SIRS, 5·8 events (5·4-6·1) per 1000 person-years for SOFA, and 2·0 events (1·8-2·2) per 1000 person-years for qSOFA. In-hospital mortality was higher for patients with an elevated qSOFA score (67 [23%] of 295 patients died) than for those with an elevated SOFA score (125 [13%] of 960 patients died) or who met SIRS criteria (128 [9%] of 1392 patients died). Mortality at 1 year after discharge was also highest for patients with an elevated qSOFA score (29·4 deaths [95% CI 22·3-38·7] per 100 person-years) compared with those with an elevated SOFA score (22·6 deaths [19·2-26·6] per 100 person-years) or those who met SIRS criteria (14·7 deaths [12·5-17·2] per 100 person-years).SIRS, SOFA, and qSOFA classifications identified different incidences and mortality. Our findings support the use of the SOFA and qSOFA classifications to identify patients with infection who are at elevated risk of poor outcomes. These classifications could be used in future epidemiological assessments and studies of patients with infection.National Institute for Nursing Research, National Center for Research Resources, and National Institute of Neurological Disorders and Stroke.

Project description: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, 49 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, 52 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.

Project description:IntroductionThe benefits and use of low-dose corticosteroids (LDCs) in severe sepsis and septic shock remain controversial. Surviving sepsis campaign guidelines suggest LDC use for septic shock patients poorly responsive to fluid resuscitation and vasopressor therapy. Their use is suspected to be wide-spread, but paucity of data regarding global practice exists. The purpose of this study was to compare baseline characteristics and clinical outcomes of patients treated or not treated with LDC from the international PROGRESS (PROmoting Global Research Excellence in Severe Sepsis) cohort study of severe sepsis.MethodsPatients enrolled in the PROGRESS registry were evaluated for use of vasopressor and LDC (equivalent or lesser potency to hydrocortisone 50 mg six-hourly plus 50 microg 9-alpha-fludrocortisone) for treatment of severe sepsis at any time in intensive care units (ICUs). Baseline characteristics and hospital mortality were analyzed, and logistic regression techniques used to develop propensity score and outcome models adjusted for baseline imbalances between groups.ResultsA total of 8,968 patients with severe sepsis and sufficient data for analysis were studied. A total of 79.8% (7,160/8,968) of patients received vasopressors, and 34.0% (3,051/8,968) of patients received LDC. Regional use of LDC was highest in Europe (51.1%) and lowest in Asia (21.6%). Country use was highest in Brazil (62.9%) and lowest in Malaysia (9.0%). A total of 14.2% of patients on LDC were not receiving any vasopressor therapy. LDC patients were older, had more co-morbidities and higher disease severity scores. Patients receiving LDC spent longer in ICU than patients who did not (median of 12 versus 8 days; P <0.001). Overall hospital mortality rates were greater in the LDC than in the non-LDC group (58.0% versus 43.0%; P <0.001). After adjusting for baseline imbalances, in all mortality models (with vasopressor use), a consistent association remained between LDC and hospital mortality (odds ratios varying from 1.30 to 1.47).ConclusionsWidespread use of LDC for the treatment of severe sepsis with significant regional and country variation exists. In this study, 14.2% of patients received LDC despite the absence of evidence of shock. Hospital mortality was higher in the LDC group and remained higher after adjustment for key determinates of mortality.

Dataset Information

Effectiveness of corticosteroids in patients with sepsis or septic shock using the new third international consensus definitions (Sepsis-3): A retrospective observational study.

Publications

Effectiveness of corticosteroids in patients with sepsis or septic shock using the new third international consensus definitions (Sepsis-3): A retrospective observational study.

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