Jena Sepsis Registry

Severe Sepsis or Septic Shock (ICD-10-GM, R65.0, R65.1) Clinical Trial

— JenaSepsisReg  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02165501
• Other study ID #: 3218-08/11
• Secondary ID: FZ 01 E0 1002
• Status: Active, not recruiting
• Phase: N/A
• First received: June 11, 2014
• Last updated: November 24, 2016
• Start date: January 2011
• Est. completion date: December 2019

Study information

• Verified date: November 2016
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1995
• Est. completion date: December 2019
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Jena University Hospital	Jena

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

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