Optimization of sepsis therapy based on patient-specific digital precision diagnostics

Not Applicable

Conditions: A41
R65.1
Other sepsis
Systemic Inflammatory Response Syndrome of infectious origin with organ failure

Registration Number: DRKS00022782

Lead Sponsor: niversitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 410

Inclusion Criteria

All patients who develop sepsis or septic shock within < 24 h in accordance with the new sepsis definition (Sepsis-3) in the above-mentioned participating centers and consent to participation in the study will be included.
General inclusion criteria:
- written consent by the study participant or a legally appointed representative
- Age >18 years
Sepsis:
- Life-threatening organ dysfunction due to a dysregulated immune response on the basis of a suspected or proven infection
- Detection of organ dysfunction indicated by SOFA score of = 2 points Alternative:
Change of the quick (q) SOFA score of 2 points as an indication of a sepsis
Or septic shock:
-Persistent hypotension despite adequate volume substitution, which necessitates the use of vasopressors, to maintain an arterial medium pressure of > 65 mmHg
-serum lactate > 2 mmol/l (18 mg/dl)

Exclusion Criteria

- Age < 18 years
- Refusal to participate in the study
- Probable discharge of the patient from the intensive care unit within the first 72 h of initial study inclusion
- Palliative therapy approach
- Death of the patient is already foreseeable or inevitable at trial inclusion
- Patients who have already been included in the study but require re-admission to the intensive care unit cannot be included a second time

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DOOR/RADAR (Desirability of Outcome Ranking / Response Adjusted for Duration of Antibiotic Risk)-Score after 28 days.

Secondary Outcome Measures

Name	Time	Method
-Mortality rate after 90 and 180 days<br>- Duration of ventilation<br>- Time to resolution of Sepsis<br>- Requirement for follow-up continuous renal replacement therapy <br>- Total hospital stay<br>- Cumulative time of antibiotic requirement<br>- Time at the beginning of the targeted antibiotic <br>-Use of therapeutic services (outpatient and inpatient)<br>- Time out of work<br>- Insurance costs (inpatient and outpatient)<br>- Health-related survey of quality of life<br>