Mid-German Sepsis Cohort

• Conditions: R65.1; R57.2; Systemic Inflammatory Response Syndrome of infectious origin with organ failure; Septic shock

• Registration Number: DRKS00010050
• Lead Sponsor: Integriertes Forschungs- und Behandlungszentrum (IFB) SepsisCenter for Sepsis Control and Care (CSCC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-22
• Results First Posted: 2021-02-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 3213

Inclusion Criteria

ICU-treated severe sepsis or septic shock

Exclusion Criteria

previous participation in the MSC-study

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional ability as defined by six activities of daily living (ADLs: walking, dressing, bathing, eating, etc.) or five instrumental activities of daily living (IADLs: preparing a hot meal, shopping for groceries, making telephone calls, etc.); taken together as activities of daily living (ADL) and instrumental activities of daily living (IADL), displayed in the so-called Frührehabilitations-Barthel-Index (FRB)” and Barthel index, respectively. Analyses are done to detect individual changes in total score between ICU discharge and current follow up: 3 months, 6 months, 12 months, 24 months, 36 months, 48 months und 60 months after ICU discharge.

Secondary Outcome Measures

Name	Time	Method
Overall and cause-specific survival, number of recurrent infections, health-related quality of life (EQ-5D-3L), cognitive deficiency score (telefon-MOCA, IQCODE), weight, return to work, posttraumatic stress (PTSS-10), anxiety and depression (PHQ-9). Inquiry at 3 months, 6 months, 12 months, 24 months, 36 months, 48 months und 60 months after ICU discharge - via interview/questionnaires.