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Do-not-resuscitate status and observational comparative effectiveness research in patients with septic shock*.

ABSTRACT: To assess the importance of including do-not-resuscitate status in critical care observational comparative effectiveness research.Retrospective analysis.All California hospitals participating in the 2007 California State Inpatient Database, which provides do-not-resuscitate status within the first 24 hours of admission.Septic shock present at admission.None.We investigated the association of early do-not-resuscitate status with in-hospital mortality among patients with septic shock. We also examined the strength of confounding of do-not-resuscitate status on the association between activated protein C therapy and mortality, an association with conflicting results between observational and randomized studies. We identified 24,408 patients with septic shock; 19.6% had a do-not-resuscitate order. Compared with patients without a do-not-resuscitate order, those with a do-not-resuscitate order were significantly more likely to be older (75?±?14 vs 67?±?16 yr) and white (62% vs 53%), with more acute organ failures (1.44?±?1.15 vs 1.38?±?1.15), but fewer inpatient interventions (1.0?±?1.0 vs 1.4?±?1.1). Adding do-not-resuscitate status to a model with 47 covariates improved mortality discrimination (c-statistic, 0.73-0.76; p < 0.001). Addition of do-not-resuscitate status to a multivariable model assessing the association between activated protein C and mortality resulted in a 9% shift in the activated protein C effect estimate toward the null (odds ratio from 0.78 [95% CI, 0.62-0.99], p = 0.04, to 0.85 [0.67-1.08], p = 0.18).Among patients with septic shock, do-not-resuscitate status acts as a strong confounder that may inform past discrepancies between observational and randomized studies of activated protein C. Inclusion of early do-not-resuscitate status into more administrative databases may improve observational comparative effectiveness methodology.

SUBMITTER: Bradford MA

PROVIDER: S-EPMC4266548 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Do-not-resuscitate status and observational comparative effectiveness research in patients with septic shock*.

Bradford Mark A MA Lindenauer Peter K PK Wiener Renda Soylemez RS Walkey Allan J AJ

Critical care medicine 20140901 9

<h4>Objectives</h4>To assess the importance of including do-not-resuscitate status in critical care observational comparative effectiveness research.<h4>Design</h4>Retrospective analysis.<h4>Setting</h4>All California hospitals participating in the 2007 California State Inpatient Database, which provides do-not-resuscitate status within the first 24 hours of admission.<h4>Patients</h4>Septic shock present at admission.<h4>Interventions</h4>None.<h4>Measurements and main results</h4>We investigat ...[more]

PMID: 24810532

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Project description:BackgroundThe 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.ObjectiveTo 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.MethodsWe 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.ResultsOf 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).ConclusionsIn 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.

Project description:BackgroundDespite the intensive efforts to improve the diagnosis and therapy of sepsis over the last decade, the mortality of septic shock remains high and causes substantial socioeconomical burden of disease. The function of immune cells is time-of-day-dependent and is regulated by several circadian clock genes. This study aims to investigate whether the rhythmicity of clock gene expression is altered in patients with septic shock.MethodsThis prospective pilot study was performed at the university hospital Charité-Universitätsmedizin Berlin, Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK). We included 20 patients with septic shock between May 2014 and January 2018, from whom blood was drawn every 4 h over a 24-h period to isolate CD14-positive monocytes and to measure the expression of 17 clock and clock-associated genes. Of these patients, 3 whose samples expressed fewer than 8 clock genes were excluded from the final analysis. A rhythmicity score SP was calculated, which comprises values between -1 (arrhythmic) and 1 (rhythmic), and expression data were compared to data of a healthy study population additionally.Results77% of the measured clock genes showed inconclusive rhythms, i.e., neither rhythmic nor arrhythmic. The clock genes NR1D1, NR1D2 and CRY2 were the most rhythmic, while CLOCK and ARNTL were the least rhythmic. Overall, the rhythmicity scores for septic shock patients were significantly (p < 0.0001) lower (0.23 ± 0.26) compared to the control group (12 healthy young men, 0.70 ± 0.18). In addition, the expression of clock genes CRY1, NR1D1, NR1D2, DBP, and PER2 was suppressed in septic shock patients and CRY2 was significantly upregulated compared to controls.ConclusionMolecular rhythms in immune cells of septic shock patients were substantially altered and decreased compared to healthy young men. The decrease in rhythmicity was clock gene-dependent. The loss of rhythmicity and down-regulation of clock gene expression might be caused by sepsis and might further deteriorate immune responses and organ injury, but further studies are necessary to understand underlying pathophysiological mechanisms. Trail registration Clinical trial registered with www.ClinicalTrials.gov (NCT02044575) on 24 January 2014.

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Do-not-resuscitate status and observational comparative effectiveness research in patients with septic shock*.

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Do-not-resuscitate status and observational comparative effectiveness research in patients with septic shock*.

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