The institutional review boards of Cooper University Hospital (Camden, New Jersey),15 University of Piitsburgh Medical Center (UPMC; a network of hospitals in western Pennsylvania), and Kaiser Permanente Northern California (KPNC)16 (link) provided ethics approvals for research using the SSC and EHR data sets, respectively.
The SSC registry includes data collected from 218 hospitals in 18 countries on 28 150 patients with suspected infection who, despite adequate fluid resuscitation as judged by the collecting sites, still had 2 or more systemic inflammatory response syndrome criteria and 1 or more organ dysfunction criteria (eMethods 3 in the Supplement). The SSC database setup, inclusion, and reporting items are described in detail elsewhere.6 (link),17 (link) To select clinical criteria for the new septic shock definition, an analysis data set was created that included all patients with a serum lactate level measurement or a mean arterial pressure less than 65 mmHg after fluids, or who received vasopressors.
For external validation, mortality was determined using the same clinical criteria in patients with suspected infection (cultures taken, antibiotics commenced) within 2 large EHR databases from UPMC (12 hospitals, 2010–2012,n = 1 309 025) and KPNC (20 hospitals, 2009–2013, n = 1 847 165). Three variables (hypotension, highest serum lactate level, and vasopressor therapy as a binary variable [yes/no]) were extracted from these 2 data sets during the 24-hour period after infection was suspected. Descriptive analyses, similar to those performed on the SSC data set, were then undertaken. Because of constraints on data availability, hypotension was considered present if systolic blood pressure was 100 mmHg or less for any single measurement taken during the 24-hour period after infection was suspected. Serum lactate levels were measured in 9% of infected patients at UPMC and in 57%of those at KPNC after implementation of a sepsis quality improvement program.
The SSC registry includes data collected from 218 hospitals in 18 countries on 28 150 patients with suspected infection who, despite adequate fluid resuscitation as judged by the collecting sites, still had 2 or more systemic inflammatory response syndrome criteria and 1 or more organ dysfunction criteria (eMethods 3 in the Supplement). The SSC database setup, inclusion, and reporting items are described in detail elsewhere.6 (link),17 (link) To select clinical criteria for the new septic shock definition, an analysis data set was created that included all patients with a serum lactate level measurement or a mean arterial pressure less than 65 mmHg after fluids, or who received vasopressors.
For external validation, mortality was determined using the same clinical criteria in patients with suspected infection (cultures taken, antibiotics commenced) within 2 large EHR databases from UPMC (12 hospitals, 2010–2012,n = 1 309 025) and KPNC (20 hospitals, 2009–2013, n = 1 847 165). Three variables (hypotension, highest serum lactate level, and vasopressor therapy as a binary variable [yes/no]) were extracted from these 2 data sets during the 24-hour period after infection was suspected. Descriptive analyses, similar to those performed on the SSC data set, were then undertaken. Because of constraints on data availability, hypotension was considered present if systolic blood pressure was 100 mmHg or less for any single measurement taken during the 24-hour period after infection was suspected. Serum lactate levels were measured in 9% of infected patients at UPMC and in 57%of those at KPNC after implementation of a sepsis quality improvement program.