Sepsis due to abdominal infection or hospital acquired pneumonia Injury, Occupational Diseases, Poisoning Complications of procedures, not elsewhere classified
Conditions
Interventions
Patients will be randomised in two groups. Samples for the LightCycler® SeptiFast Test will be taken in both groups parallel to conventional blood cultures. In group 1, the results of the LightCycler®
Sponsors
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Post-surgical patients with suspected intra-abdominal infection or hospital acquired pneumonia 2. Suspected or known infection that clinically indicates investigation by blood cultures 3. Inclusion within 72 hours of diagnosis 4. Presence of at least two criteria for systemic inflammatory response syndrome (SIRS): 4.1. Temperature greater than 38°C or less than 36°C 4.2. Heart rate greater than 90 beats/minute 4.3. Respiratory rate greater than 20 breaths/minute or partial pressure of carbon dioxide in arterial blood (PaCO2) less than 32 mmHg/4.3 kPa 4.4. White blood cell count (WBC) greater than 12.000/mm^3 or less than 4.000/mm^3 or 10% immature 5. Age greater than 17 years, either sex
Exclusion criteria
Exclusion criteria: 1. Moribund patients with expected survival less than 24 hours 2. Less than 18 years of age 3. Pregnancy 4. Known and confirmed organism responsible for infection 5. Participation in an other prospective clinical study during the passed 30 days 6. Consent of the patient or legal guardian cannot be obtained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of changes of the initial antibiotic treatment related to diagnostic procedures and time until appropriate antibiotic treatment, assessed at the end of data collection. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of patients with organisms detected by the LightCycler® SeptiFast Test compared to all patients with clinically confirmed sepsis 2. Rate of empirical treatment that was retrospectively confirmed to be appropriate 3. Number of days with antibiotic treatment 4. Decreasing severity of illness (Simplified Acute Physiology Score [SAPS], Sequential Organ Failure Assessment [SOFA], 28-item Therapeutic Intervention Score [TISS-28]) during treatment 5. Length of mechanical ventilation 6. Length of intensive care unit (ICU) stay 7. Length of hospital stay 8. Therapy costs All assessed at the end of data collection. | — |
Countries
Germany
Outcome results
None listed