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Withdrawn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
About this trial
This is an interventional diagnostic trial for Sepsis focused on measuring sepsis, septic shock, contrast-enhanced ultrasound, microcirculation
Eligibility Criteria
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
NCT ID
NCT02277977
First Posted
October 27, 2014
Last Updated
August 30, 2022
Sponsor
University Hospital Freiburg
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Withdrawn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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