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
1 other identifier
observational
36
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 17, 2009
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 21, 2024
August 1, 2024
12.1 years
April 16, 2009
August 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Microvascular Flow Index (MFI)
6 hours after treatment
Secondary Outcomes (1)
Leukocyte - endothelial cell interactions, red blood cell velocity
6 hours after treatment
Study Arms (2)
Controls
Patients with ileostomy.
Standard Sepsis Treatment
Patients with ileostomy and sepsis
Eligibility Criteria
Patients presenting to ICU with sepsis and ileostomy
You may qualify if:
- 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
You may not qualify if:
- infection at the site of stoma,
- moribund patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Elizabeth II Health Sciences Cetnre
Halifax, Nova Scotia, B3H 2Y9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2009
First Posted
April 17, 2009
Study Start
November 1, 2011
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
August 21, 2024
Record last verified: 2024-08