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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Herlev Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00378586
First received: September 19, 2006
Last updated: June 22, 2009
Last verified: June 2009
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Michael Ibsen, Rigshospitalet
ClinicalTrials.gov 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
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on August 18, 2014