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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00022782
Enrollment
410
Registered
2020-08-25
Start date
2022-03-16
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A41 R65.1

Interventions

Group 1: Only standard diagnostics (Microbial diagnostics by means of standard culture methods + optional consultation of experts in the field of infectious diseases) within the first 72 h after diagn

Sponsors

Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients who develop sepsis or septic shock within 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

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Contacts

Public ContactThorsten Brenner

Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin

thorsten.brenner@uk-essen.de+49 (0)201 723 – 1401

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026