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Clinical Trials/DRKS00003579
DRKS00003579
Recruiting
Not Applicable

ong-term Immunological Sequelae in Sepsis-Survivors - LOSS

niversitätsklinikum JenaFriedrich-Schiller-UniversitätCenter for Sepsis Control and Care (CSCC)0 sites59 target enrollmentFebruary 29, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
SepsisSevere SepsisSeptic Shock
Sponsor
niversitätsklinikum JenaFriedrich-Schiller-UniversitätCenter for Sepsis Control and Care (CSCC)
Enrollment
59
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 29, 2012
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
niversitätsklinikum JenaFriedrich-Schiller-UniversitätCenter for Sepsis Control and Care (CSCC)

Eligibility Criteria

Inclusion Criteria

  • Key Inclusion Criteria Patient:
  • 1\.Sepsis, Severe sepsis, or septic shock based on the definitions by the ACCP/SCCM Consensus Conference:
  • \- Sepsis: SIRS with documented infection
  • \-\-\>SIRS: presence of at least two criteria:
  • 1\) body temperature \<36°C or \>38°C),
  • 2\) tachycardia (\>90 beats/min),
  • 3\) tachypnea (\>20 breaths/min or PaCO2\< 4\.3kPa \[32 mmHg], or need for mechanical ventilation),
  • 4\) white blood count \<4000 cells/µl or \>12,000 cells/µl.
  • \-\-\> Infection: defined by the International Sepsis Forum Consensus Conference on Definitions of Infection in the Intensive Care Unit.
  • \-Severe sepsis: sepsis with at least one manifestation of inadequate organ perfusion or function:

Exclusion Criteria

  • Key Exclusion Criteria Patient:
  • 1\. Systemic autoimmune disease, malignant hemopathy, HIV infection, transplantation, immunosuppressive medication (corticosteroids with \>10mg prednisolone equivalent/day)
  • 2\. Chemo\- or radiotherapy due to malignancy
  • 3\. End\-stage chronic liver disease (Child\-Pugh C)
  • 4\. End\-stage chronic kidney disease (requiring renal replacement therapy)
  • 5\. Extracorporeal circulation and/or membrane oxygenation
  • 6\. Ischemic stroke or intracranial bleeding within last three months
  • 7\. Pregnancy and nursing
  • 8\. Participation in interventional study
  • Key Exclusion Criteria Healthy Control:

Outcomes

Primary Outcomes

Not specified

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