DRKS00022782
Completed
未知
Optimization of sepsis therapy based on patient-specific digital precision diagnostics - DigiSep - Trial
niversitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin0 sites410 target enrollmentAugust 25, 2020
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- A41
- Sponsor
- niversitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
- Enrollment
- 410
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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