PROGRESS, an international web-based severe sepsis registry, was created to provide a representative, contemporary description of severe sepsis worldwide. We compare baseline characteristics of over 4000 severe sepsis patients enrolled to date in PROGRESS with characteristics of placebo patients from the severe sepsis combined clinical trial database, INDEPTH.
PROGRESS is a prospective, observational registry. Participating ICUs enroll patients who have severe sepsis (suspected or proven infection and ≥1 acute sepsis-induced organ dysfunction). All data handling is by secure website and all patient data are de-identified. An independent advisory committee with professional society representation governs PROGRESS. PROGRESS software development and website maintenance was funded by Eli Lilly. INDEPTH placebo patients are from 4 severe sepsis clinical trials conducted in 13 countries. All of the INDEPTH trials had similar entry criteria and were conducted by the same sponsor (Eli Lilly). Exclusion criteria differed in the INDEPTH trials and PROGRESS has no exclusion criteria.
As of April 1, 2004, PROGRESS has enrolled 4387 severe sepsis patients in 32 countries. Baseline characteristics of PROGRESS patients are compared with those of INDEPTH placebo patients in the tableINDEPTH Combined Severe Sepsis Clinical Trial Database Placebo Patients N=1231PROGRESS Severe Sepsis Registry N=4387Age, mean ± SD60.3±16.559.1±18.8Male, %57.659.4Caucasian, %79.452.6APACHE II, mean ± SD24.6±7.822.2±8.2Multiple organ dysfunction (%)78.087.7Mechanical ventilation (%)78.383.5Vasopressors (%)64.179.5Cardiovascular organ dysfunction (%)73.274.3Respiratory organ dysfunction (%)77.582.3Lung as site of infection (%)52.146.6.
Many of the disease severity measures examined indicate the “real-life” patients enrolled in PROGRESS are more severe at baseline. Absence of exclusion criteria in PROGRESS may lead to enrollment of more severe patients. Further comparisons must take into account these and other differences, such as possible country variations.
Differences in baseline disease severity between clinical trial patients and clinical practice patients may potentially influence outcomes observed with new therapies.
R. Beale, I have served as a consultant to Eli Lilly & Co.