Table 2 Primary and secondary outcomes of DigiSep-trial
Outcomes | Data source | Timepoint/frame |
|---|---|---|
Primary outcomes | ||
DOOR/RADAR score | eCRF | 28 days |
Secondary outcomes | ||
Long term mortality | Statutory health insurance data, eCRF | 90, 180 days |
Degree of organ dysfunction/failure: • Duration of mechanical ventilation • Length of time until shock resolution • Ongoing RRT-dependency | eCRF | 28, 90, 180 days |
Hospital length of stay | Statutory health insurance data, eCRF | 28, 90, 180 days |
Cumulative need for anti-infective drugs | Statutory health insurance data, eCRF | 28, 90, 180 days |
Beginning of a targeted anti-infective treatment regimen | eCRF | 28 days |
Resource utilization (outpatient and inpatient) | Statutory health insurance data | 28, 90, 180 days |
Duration and costs of incapacity to work | Statutory health insurance data | 28, 90, 180 days |
Direct medical costs (outpatient and inpatient) | Statutory health insurance data | 28, 90, 180 days |
Quality-of-life (QoL) | VR-36 questionnaire | 0, 90, 180 days |