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Sidestream Dark-Field (SDF) Imaging of the Intestinal Microcirculation
This study is not yet open for participant recruitment.
Verified by Capital District Health Authority, Canada, April 2009
First Received: April 16, 2009   No Changes Posted
Sponsored by: Capital District Health Authority, Canada
Information provided by: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00883597
  Purpose

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 APC 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).


Condition
Sepsis

MedlinePlus related topics: Sepsis
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Sidestream Dark-Field Imaging of the Intestinal Microcirculation in Clinical Sepsis: The Impact of Activated Protein C Therapy

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Microvascular Flow Index (MFI) [ Time Frame: 6 hours after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Leukocyte - endothelial cell interactions, red blood cell velocity [ Time Frame: 6 hours after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: June 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
Patients with ileostomy.
Standard Sepsis Treatment
Patients with ileostomy and sepsis
Activated Protein C
Patients with ileostomy and sepsis

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting to ICU with sepsis and ileostomy

Criteria

Inclusion Criteria:

  • ileostomy, no infection at the site of stoma, informed consent.
  • diagnosed sepsis according to ACCP/SCCM criteria13.
  • indication for treatment according to hospital guidelines

Exclusion Criteria:

  • infection at the site of stoma,
  • moribund patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883597

Contacts
Contact: Christian Lehmann, MD 902-494-2493 chlehmann@dal.ca
Contact: Sara Whynot, MLT 902-494-2493 scwhynot@dal.ca

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Cetnre
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Capital District Health Authority, Canada
  More Information

No publications provided

Responsible Party: Capital District Health Authority ( Christian Lehmann, MD )
Study ID Numbers: CDHA-RS/2009-311
Study First Received: April 16, 2009
Last Updated: April 16, 2009
ClinicalTrials.gov Identifier: NCT00883597     History of Changes
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Sepsis
Protein C
Inflammation

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Sepsis
Pathologic Processes
Infection
Inflammation

ClinicalTrials.gov processed this record on May 06, 2009