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Tusep: Inflammatory Mediators in Early Sepsis

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Recruiting
CT.gov ID
NCT02692118
Collaborator
(none)
60
Enrollment
1
Location
69
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sepsis is still a challenge for clinicians since the detailed pathomechanism are still unknown and until now early markers for sepsis are not defined yet. Immunological pathways and new mediators defined in animal models are not yet investigated in patients with sepsis. Therefore the investigators will measure new mediators in patients with septic shock.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Semaphorins 1 to 7 will be determined in Blood of patients with early septic shock. Concentration will be compared with blood concentration of postoperative patients suffering systemic inflammatory response syndrome (SIRS).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Inflammatory Mediators in Sepsis as Indicator for Infection vs Inflammation
    Actual Study Start Date :
    Dec 1, 2016
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    sepsis

    Patients with septic shock admitted to ICU

    Outcome Measures

    Primary Outcome Measures

    1. Semaphorin 1 to 7 in plasma of septic patients [12 months]

      Concentration of Semaphorin in plasma of 60 sepsis patients [pg/ml].

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Septic Shock
    Exclusion Criteria:

    • Age < 18 > 85

    • no consent of caregiver

    • Trauma patients

    • Burn patients

    • Immunosuppression

    • Pregnancy

    • HIV- hepatitis infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Tuebingen Tuebingen Germany 72076

    Sponsors and Collaborators

    • University Hospital Tuebingen

    Investigators

    • Principal Investigator: Peter Rosenberger, MD, University Hospital Tuebingen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Tuebingen
    ClinicalTrials.gov Identifier:
    NCT02692118
    Other Study ID Numbers:
    • AnaTubingen
    First Posted:
    Feb 25, 2016
    Last Update Posted:
    Jun 7, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Inflammation

    Study Results

    No Results Posted as of Jun 7, 2021