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NCT00883597 Clinical Trial

Sidestream Dark-Field (SDF) Imaging of the Intestinal Microcirculation

Sepsis Clinical Trial

Official title:
Sidestream Dark-Field Imaging of the Intestinal Microcirculation in Clinical Sepsis: The Impact of Activated Protein C Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00883597
Other study ID # CDHA-RS/2009-311
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 2011
Est. completion date December 2024

Study information
Verified date March 2022
Source Nova Scotia Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 36
Est. completion date December 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Queen Elizabeth II Health Sciences Cetnre Halifax Nova Scotia

Sponsors (3)
Lead Sponsor Collaborator
Christian Lehmann Nova Scotia Health Authority, Nova Scotia Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microvascular Flow Index (MFI) 6 hours after treatment
Secondary Leukocyte - endothelial cell interactions, red blood cell velocity 6 hours after treatment
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