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Evaluation of Impaired Microcirculation During Septic Shock With Contrast Enhanced Ultrasound

Primary Purpose

Sepsis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Contrast enhanced ultrasound
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sepsis focused on measuring sepsis, septic shock, contrast-enhanced ultrasound, microcirculation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • septic shock

Exclusion Criteria:

  • myocardial infarction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Contrast enhanced ultrasound

    Arm Description

    Contrast enhanced ultrasound during septic shock

    Outcomes

    Primary Outcome Measures

    Contrast transit time during and after septic shock

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 2014
    Last Updated
    August 30, 2022
    Sponsor
    University Hospital Freiburg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02277977
    Brief Title
    Evaluation of Impaired Microcirculation During Septic Shock With Contrast Enhanced Ultrasound
    Official Title
    Messung Von Mikrozirkulationsstörungen im Septischen Schock Mit Kontrastmittel- verstärkter Sonographie Evaluation of Impaired Microcirculation During Septic Shock With Contrast Enhanced Ultrasound
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    November 2014 (Anticipated)
    Primary Completion Date
    November 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital Freiburg

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Microcirculatory disorders play a central role in the pathogenesis of sepsis and septic shock. Without adequate therapy that may lead to multi-organ failure and death. Therefore useful therapeutic measures aim to improve the microcirculation, to avoid tissue hypoxia and thus multiple organ failure or death. Clinically, the microcirculation can currently be indirectly evaluated using the diuresis and metabolic parameters (eg, lactate). The aim of the present study is to measure the microcirculation in septic shock by means of contrast-enhanced sonography of the calf muscles. For this purpose, the method is applied to 24 subjects during and after septic shock. It will be investigated in this study whether the microcirculation measurement with ultrasound contrast reflects the severity of the disease. As well as to evaluate whether the use of this diagnostic method could lead to better treatment of the septic shock.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sepsis
    Keywords
    sepsis, septic shock, contrast-enhanced ultrasound, microcirculation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Contrast enhanced ultrasound
    Arm Type
    Experimental
    Arm Description
    Contrast enhanced ultrasound during septic shock
    Intervention Type
    Other
    Intervention Name(s)
    Contrast enhanced ultrasound
    Intervention Description
    Contrat enhanced ultrasound during septic shock
    Primary Outcome Measure Information:
    Title
    Contrast transit time during and after septic shock
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: septic shock Exclusion Criteria: myocardial infarction
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Duerschmied, MD, PHD
    Organizational Affiliation
    University of Freiburg
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Impaired Microcirculation During Septic Shock With Contrast Enhanced Ultrasound

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