Definition of clinical subtypes of sepsis and septic shock using statistical analysis of digital patient records.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039271

Enrollment

3000

Registered

2026-02-06

Start date

2026-01-10

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

A41 R65.1 R57.2

Interventions

Group 1: Retrospective, single-center cohort of adult intensive care patients meeting Sepsis-3 criteria for sepsis or septic shock. Data are exclusively derived from pseudonymized electronic patient r

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Admission to an intensive care unit at the study center during the defined study period Age = 18 years Fulfillment of Sepsis-3 criteria for sepsis or septic shock Clinical suspicion of infection with initiation of antibiotic therapy and blood culture sampling Organ dysfunction defined by SOFA score = 2 Availability of relevant routine clinical data in the PDMS (vital signs, laboratory parameters, medications, longitudinal data)

Exclusion criteria

Exclusion criteria: incomplete or missing core clinical data precluding statistical analysis or subtype classification Duplicate patient entries (only first ICU admission considered) Age < 18 years Withdrawal of consent for secondary use of clinical data, if applicable under data protection regulations

Design outcomes

Primary

Measure	Time frame
Identification and definition of clinically homogeneous subtypes of sepsis and septic shock using data-driven statistical modeling and unsupervised clustering based on routinely collected clinical variables.	—

Secondary

Measure	Time frame
Characterization of subtype-specific clinical features (vital signs, laboratory parameters, medications, microbiology, scores, comorbidities). Comparison of clinical trajectories and outcomes between subtypes (e.g., organ dysfunction/SOFA, vasopressor requirement, duration of mechanical ventilation, ICU and hospital length of stay, mortality). Assessment of robustness and reproducibility of identified clusters (internal validation). Exploratory identification of predictors of subtype assignment.	—

Measure

Time frame

Characterization of subtype-specific clinical features (vital signs, laboratory parameters, medications, microbiology, scores, comorbidities). Comparison of clinical trajectories and outcomes between subtypes (e.g., organ dysfunction/SOFA, vasopressor requirement, duration of mechanical ventilation, ICU and hospital length of stay, mortality). Assessment of robustness and reproducibility of identified clusters (internal validation). Exploratory identification of predictors of subtype assignment.

—

Countries

Germany

Contacts

Public ContactMartin Schlegel

TUM Universitätsklinikum

martin.schlegel@mri.tum.de+49 89 4140 8676

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026