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OpenTrials
Completed

NCT Number: NCT00883597

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

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).

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Elizabeth II Health Sciences Cetnre

Halifax, Nova Scotia, B3H 2Y9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Microvascular Flow Index (MFI)

    Time frame: 6 hours after treatment

Secondary outcomes

  1. Leukocyte - endothelial cell interactions, red blood cell velocity

    Time frame: 6 hours after treatment

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Nova Scotia Health Research Foundation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2009
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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