Jena Sepsis Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1995 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

\-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jochen Gensichen, MD, MA, MPH

Professor and Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jena University Hospital

Jena, , Germany

Site Status

Countries

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Germany

Other Identifiers

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FZ 01 E0 1002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

3218-08/11

Identifier Type: -

Identifier Source: org_study_id