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Barrier Function and Production of Inflammatory Cytokines in the Rectal Mucosa in Patients With Septic Shock

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Herlev Hospital.
Recruitment status was:  Not yet recruiting
Information provided by:
Herlev Hospital Identifier:
First received: September 19, 2006
Last updated: June 22, 2009
Last verified: June 2009

Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of different inflammatory and infectious markers.

The investigators hypothesize, therefore, that there is a significant difference in the concentrations of inflammatory and infectious markers in the rectal mucosa between patients with septic shock and healthy controls.

Condition Intervention
Septic Shock
Procedure: Rectal biopsy
Procedure: Measurement of inflammatory markers in the rectal mucosa
Procedure: Measurement of rectal lactic acid

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Barrier Function and Production of Inflammatory Cytokines in the Rectal Mucosa in Patients With Septic Shock

Resource links provided by NLM:

Further study details as provided by Herlev Hospital:

Estimated Enrollment: 30
Study Start Date: January 2010
Intervention Details:
    Procedure: Rectal biopsy
    Rectal biopsy.
    Procedure: Measurement of inflammatory markers in the rectal mucosa
    IL-6, TNF-alfa.
    Procedure: Measurement of rectal lactic acid
    Equilibrium dialysis.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Septic shock patients.

Inclusion Criteria:

  • Septic shock

Exclusion Criteria:

  • Age < 18 years
  • No next of kin
  • Pathology of the descending or sigmoid colon or rectum
  • Pregnancy
  • 1st degree relatives with inflammatory bowel disease
  • Severe coagulopathy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00378586

Dept. of Intensive Care 4131
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Herlev Hospital
Principal Investigator: Michael Ibsen, MD Dept. of Intensive Care 4131, Rigshospitalet, Copenhagen, Denmark
  More Information

Responsible Party: Michael Ibsen, Rigshospitalet Identifier: NCT00378586     History of Changes
Other Study ID Numbers: KA-05037 
Study First Received: September 19, 2006
Last Updated: June 22, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Inflammation processed this record on December 09, 2016