Alterations of Immunologic Mediators During Severe Sepsis

NCT00484146 | Terminated

• 1 other identifier: ISRCTN34508816
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Severe sepsis induces significant changes in expression of insulin- and toll-like receptors, cytokines, markers of apoptosis, and activation of t- and b-lymphocytes.

Conditions

Severe Sepsis

Keywords

Sepsis; Early Stage; Immune System; Receptors; Cytokines

Outcome Measures

Primary Outcomes (1)

• severity of sepsis

  SOFA-Score

  96 hours after diagnosis of sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with early stage of severe sepsis and septic shock

You may qualify if:

• age \>= 18 y
• agreement with study procedures
• of 4 SIRS-criteria
• proven or highly suspected infection
• or more sepsis-induced organ failures
• start of first sepsis-induced organ failure within the last 36 hours

You may not qualify if:

• non-agreement with study procedures
• signs of severe sepsis with organ failure \> 36 hours
• chronic immuno-compromising diseases
• chronic therapy with anti-inflammatory drugs
• non-curable cancer
• chronic renal failure with hemodialysis
• pregnancy or breast-feeding

Sponsors & Collaborators

• Klinikum St. Georg gGmbH: lead
• University of Halle Medical Faculty: collaborator

Study Sites (1)

Klinikum St. Georg gGmbH, Interdisciplinary Intensive Care Unit

Leipzig, Saxony, 04129, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole Blood Samples, Plasma Samples

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Armin R Sablotzki, MD

  Klinikum St. Georg gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 8, 2007
• Study Start: June 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

DE (1)