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

March 7, 2022 updated by: Christian Lehmann

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Cetnre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to ICU with sepsis and ileostomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Controls
Patients with ileostomy.
Standard Sepsis Treatment
Patients with ileostomy and sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Microvascular Flow Index (MFI)
Time Frame: 6 hours after treatment
6 hours after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Leukocyte - endothelial cell interactions, red blood cell velocity
Time Frame: 6 hours after treatment
6 hours after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 16, 2009

First Submitted That Met QC Criteria

April 16, 2009

First Posted (Estimate)

April 17, 2009

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CDHA-RS/2009-311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

3
Subscribe