Jena Sepsis Registry

• Conditions: Severe Sepsis or Septic Shock (ICD-10-GM, R65.0, R65.1)

• Registration Number: NCT02165501
• Lead Sponsor: University of Jena

Brief Summary

Despite the burden of severe sepsis and septic shock deficiencies in the quality of sepsis management are recognized. Investigators present a population-based registry with easy feasibility as part of German Center for Sepsis Control \& Care (CSCC). All ICU patients of the Jena University Hospital, Germany will be screened for inclusion (severe sepsis or septic shock). Baseline data on ICU- and hospital care will be extracted from patient records at ICU discharge. The primary outcome is change in all-cause mortality from baseline to follow up at 6, 12, 24, 36, 48 and 60 months after diagnosis of sepsis. Follow-up data will be collected from the primary care provider of the patient. The registry may provide valid data on quality in sepsis care.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-17
• Primary Completion: 2015-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-24
• Last Update Posted: 2016-11-28
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1995

Inclusion Criteria

• Patients treated in one of the ICUs will be enrolled if they were 18 years or older and fulfill the diagnostic criteria of severe sepsis or septic shock (ICD-10-GM, R65.0, R65.1) (19), (20).
• Diagnosis of severe sepsis or septic shock requires the following criteria: a microbiologically documented and/or clinically evident infection, at least two of the four criteria of the systemic inflammatory response syndrome (SIRS) and at least one new organ dysfunction, remote from the site of infection.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all cause mortality	change from baseline to 6,12, 24, 36, 48 and 60 months after ICU discharge	based on data from hospital records as well as patient records of the primary care provider.

Trial Locations

Locations (1)

Jena University Hospital; 🇩🇪 Jena, Germany