- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00883597
Sidestream Dark-Field (SDF) Imaging of the Intestinal Microcirculation
Sidestream Dark-Field Imaging of the Intestinal Microcirculation in Clinical Sepsis: The Impact of Activated Protein C Therapy
Sepsis is the most frequent cause of death in critically ill patients in non-coronary care Intensive Care Units in the developed world. Microcirculatory disturbances are central to the development of the disorder, leading to organ dysfunction, multi-organ failure and fatal outcome.
In particular the intestinal microcirculation is impaired early in the course of the disease. This may result in a breakdown of the gut barrier function with translocation of bacteria and their toxins into the systemic circulation, thus sustaining a "gut derived" septic state. Therefore, the impaired intestinal microcirculation has been suggested to act as the "motor of multiple organ failure" in sepsis.
The aim of the project is to evaluate a new diagnostic tool and the impact of Activated Protein C administration on the intestinal microcirculation in patients with severe sepsis and compare the findings with septic patients who are not candidates for APC therapy and healthy patients post bowel surgery using an innovative diagnostic tool (side stream dark-field imaging, SDF).
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- Queen Elizabeth II Health Sciences Cetnre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ileostomy, no infection at the site of stoma, informed consent.
- diagnosed sepsis according to American College of Chest Physicians/Society of Critical Care Medicine criteria13.
- indication for treatment according to hospital guidelines
Exclusion Criteria:
- infection at the site of stoma,
- moribund patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Controls
Patients with ileostomy.
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Standard Sepsis Treatment
Patients with ileostomy and sepsis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Microvascular Flow Index (MFI)
Time Frame: 6 hours after treatment
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6 hours after treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Leukocyte - endothelial cell interactions, red blood cell velocity
Time Frame: 6 hours after treatment
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6 hours after treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDHA-RS/2009-311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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