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| Sponsor: | Capital District Health Authority, Canada |
|---|---|
| Information provided by: | Capital District Health Authority, Canada |
| ClinicalTrials.gov Identifier: | NCT00883597 |
Purpose
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).
| Condition |
|---|
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Sepsis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: 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: | January 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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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Eligibility| 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:
Contacts and Locations| 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 | Not yet recruiting |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Principal Investigator: Christian Lehmann, MD | |
More Information
| Responsible Party: | Christian Lehmann, MD, Capital District Health Authority |
| ClinicalTrials.gov Identifier: | NCT00883597 History of Changes |
| Other Study ID Numbers: | CDHA-RS/2009-311 |
| Study First Received: | April 16, 2009 |
| Last Updated: | January 27, 2011 |
| Health Authority: | Canada: Health Canada |
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Sepsis Toxemia Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Protein C Anticoagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |