This trial is active, not recruiting.

Condition sepsis
Sponsor Christian Lehmann
Collaborator Nova Scotia Health Research Foundation
Start date November 2011
End date December 2016
Trial size 36 participants
Trial identifier NCT00883597, CDHA-RS/2009-311


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients with ileostomy.
Patients with ileostomy and sepsis

Primary Outcomes

Microvascular Flow Index (MFI)
time frame: 6 hours after treatment

Secondary Outcomes

Leukocyte - endothelial cell interactions, red blood cell velocity
time frame: 6 hours after treatment

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title Sidestream Dark-Field Imaging of the Intestinal Microcirculation in Clinical Sepsis: The Impact of Activated Protein C Therapy
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Nova Scotia Health Authority.