Sidestream Dark-Field (SDF) Imaging of the Intestinal Microcirculation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00883597|
Recruitment Status : Active, not recruiting
First Posted : April 17, 2009
Last Update Posted : January 31, 2017
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 or disease|
|Study Type :||Observational|
|Estimated Enrollment :||36 participants|
|Official Title:||Sidestream Dark-Field Imaging of the Intestinal Microcirculation in Clinical Sepsis: The Impact of Activated Protein C Therapy|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Patients with ileostomy.
Standard Sepsis Treatment
Patients with ileostomy and sepsis
- Microvascular Flow Index (MFI) [ Time Frame: 6 hours after treatment ]
- Leukocyte - endothelial cell interactions, red blood cell velocity [ Time Frame: 6 hours after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883597
|Canada, Nova Scotia|
|Queen Elizabeth II Health Sciences Cetnre|
|Halifax, Nova Scotia, Canada, B3H 2Y9|