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Sponsored by: |
Capital District Health Authority, Canada |
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Information provided by: | Capital District Health Authority, Canada |
ClinicalTrials.gov Identifier: | NCT00883597 |
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 APC 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).
Condition |
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Sepsis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Sidestream Dark-Field Imaging of the Intestinal Microcirculation in Clinical Sepsis: The Impact of Activated Protein C Therapy |
Estimated Enrollment: | 36 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Controls
Patients with ileostomy.
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Standard Sepsis Treatment
Patients with ileostomy and sepsis
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Activated Protein C
Patients with ileostomy and sepsis
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Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients presenting to ICU with sepsis and ileostomy
Inclusion Criteria:
Exclusion Criteria:
Contact: Christian Lehmann, MD | 902-494-2493 | chlehmann@dal.ca |
Contact: Sara Whynot, MLT | 902-494-2493 | scwhynot@dal.ca |
Canada, Nova Scotia | |
Queen Elizabeth II Health Sciences Cetnre | |
Halifax, Nova Scotia, Canada, B3H 2Y9 |
Responsible Party: | Capital District Health Authority ( Christian Lehmann, MD ) |
Study ID Numbers: | CDHA-RS/2009-311 |
Study First Received: | April 16, 2009 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00883597 History of Changes |
Health Authority: | Canada: Health Canada |
Systemic Inflammatory Response Syndrome Sepsis Protein C Inflammation |
Systemic Inflammatory Response Syndrome Sepsis Pathologic Processes Infection Inflammation |