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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Nova Scotia Health Research Foundation
Capital District Health Authority, Canada
Information provided by (Responsible Party):
Christian Lehmann, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00883597
First received: April 16, 2009
Last updated: March 5, 2014
Last verified: March 2014
  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 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).


Condition
Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sidestream Dark-Field Imaging of the Intestinal Microcirculation in Clinical Sepsis: The Impact of Activated Protein C Therapy

Resource links provided by NLM:


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: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
Patients with ileostomy.
Standard Sepsis Treatment
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883597

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

No publications provided

Responsible Party: Christian Lehmann, MD FRCPC, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00883597     History of Changes
Other Study ID Numbers: CDHA-RS/2009-311
Study First Received: April 16, 2009
Last Updated: March 5, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 19, 2014