Jena Sepsis Registry (JenaSepsisReg)

Jena Sepsis Registry - a Sepsis-registry for Long Term Outcomes

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 1995

Contacts and Locations

Study Locations

• Germany
  • Jena, Germany, 07743
    • Jena University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients will be selected from Jena University Hospital, Germany

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Jena

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (ESTIMATE): June 17, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 24, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 3218-08/11; FZ 01 E0 1002 (OTHER_GRANT: Federal Ministry of Education and Research (BMBF))