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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00378586
First Posted: September 20, 2006
Last Update Posted: June 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Herlev Hospital
  Purpose

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.
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378586


Contacts
Contact: Michael Ibsen, MD + 45 45 35 94 18 micibs@dadlnet.dk
Contact: Anders Perner, MD, PhD + 45 45 35 41 31 ap@dadlnet.dk

Locations
Denmark
Dept. of Intensive Care 4131 Not yet recruiting
Copenhagen, Denmark, DK-2100
Contact: Michael Ibsen, MD    +45 45 35 94 18    micibs@dadlnet.dk   
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Michael Ibsen, MD Dept. of Intensive Care 4131, Rigshospitalet, Copenhagen, Denmark
  More Information

Responsible Party: Michael Ibsen, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00378586     History of Changes
Other Study ID Numbers: KA-05037
First Submitted: September 19, 2006
First Posted: September 20, 2006
Last Update Posted: June 23, 2009
Last Verified: June 2009

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