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Jena Sepsis Registry (JenaSepsisReg)

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ClinicalTrials.gov Identifier: NCT02165501
Recruitment Status : Unknown
Verified November 2016 by Jochen Gensichen, MD, MA, MPH, Jena University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 17, 2014
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Jochen Gensichen, MD, MA, MPH, Jena University Hospital

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.

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1995 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Months
Official Title: Jena Sepsis Registry - a Sepsis-registry for Long Term Outcomes
Study Start Date : January 2011
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis




Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients will be selected from Jena University Hospital, Germany
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165501


Locations
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Germany
Jena University Hospital
Jena, Germany, 07743
Sponsors and Collaborators
University of Jena

Additional Information:
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Responsible Party: Jochen Gensichen, MD, MA, MPH, Professor and Chair, Jena University Hospital
ClinicalTrials.gov Identifier: NCT02165501     History of Changes
Other Study ID Numbers: 3218-08/11
FZ 01 E0 1002 ( Other Grant/Funding Number: Federal Ministry of Education and Research (BMBF) )
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes