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

Completed

• Conditions: Sepsis

• Registration Number: NCT00883597
• Lead Sponsor: Nova Scotia Health Authority

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-16
• Study First Posted: 2009-04-17
• Study Start: 2011-11
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microvascular Flow Index (MFI)	6 hours after treatment

Secondary Outcome Measures

Name	Time	Method
Leukocyte - endothelial cell interactions, red blood cell velocity	6 hours after treatment

Trial Locations

Locations (1)

Queen Elizabeth II Health Sciences Cetnre; 🇨🇦 Halifax, Nova Scotia, Canada