Lead Investigator: Thomas Metkus, Johns Hopkins University School of Medicine
Title of Proposal Research: Severe sepsis in the cardiac intensive care unit: management strategies and outcomes
Vivli Data Request: 5166
Funding Source: None.
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Patients in the contemporary cardiac intensive care unit (CICU) present with an increasing frequency of non-cardiac critical illness syndromes including severe sepsis (Jentzer et al., 2019; Vallabhajosyula et al., 2019). Cardiac patients with severe sepsis have a higher frequency of conditions that could impact sepsis management including heart failure, valvular disease, arrhythmia, and ischemic heart disease (Bohula et al., 2019; Katz et al., 2016; Morrow et al., 2012). Moreover, cardiac patients with severe sepsis may have sepsis sources that differ from the general population such as infected cardiac implantable devices (Kusumoto et al., 2017) or endocarditis (Cahill et al.,2017). Whether current paradigms and guidelines for sepsis management (Levy, Evans, & Rhodes, 2018) apply to cardiac patients with severe sepsis is not known. Therefore, we aim to compare CICU patients with severe sepsis to the general population of severe sepsis patients.
We hypothesize that demographics, source of sepsis and management strategies will differ substantially for septic cardiac patients and that outcomes will be worse with high rates of in-hospital mortality. Successful completion of our aims will provide impetus for prospective intervention trials is septic cardiac patients, inform CICU staffing and prognostication, and inform future iterations of sepsis guidelines. To fill these gaps in knowledge, we propose an international retrospective cohort study of patients with severe sepsis enrolled in the PROGRESS registry (Beale et al., 2010; Beale et al., 2009; Martin et al., 2009) of severe sepsis.
Statistical Analysis Plan:
The PROGRESS cohort includes 12,570 patients with severe sepsis across 276 centers and 37 countries. Enrollment occurred from December 2002 to December 2005. We will include all patients with primary outcome and exposure data available. We will compare demographics and clinical characteristics across categorical categories of the exposure variable using appropriate parametric or nonparametric tests for continuous variables and the Chi Square test for categorical variables. We will use logistic regression to determine the association of CICU admission with mortality adjusting for demographics and degree of critical illness. We will compare ICU and hospital length of stay across the exposure category using linear regression with variable transformations as appropriate to ensure the assumptions of linear regression are satisfied. We will also perform a time to event analysis using the Kaplan Meier method for the primary outcome across ICU exposure categories. We will also perform Cox proportional hazard models for the primary outcome adjusting for the above noted factors. We will ensure the proportional hazards assumption is met for all models.
An International Observational Study Among Severe Sepsis Patients Treated in the Intensive Care Unit
Sponsor: Eli Lilly and Company
Study ID: F1K-MC-EVBJ
Sponsor ID: F1K-MC-EVBJ
Dugan, Eunice; Stephens, R. Scott; Schulman, Steven; Metkus, Thomas 1205: Sepsis in the Cardiac Intensive Care Unit: Demographics and Outcomes, Critical Care Medicine: January 2021 – Volume 49 – Issue 1 – p 605