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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00378586
Other study ID # KA-05037
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 19, 2006
Last updated June 22, 2009
Start date January 2010

Study information

Verified date June 2009
Source Herlev Hospital
Contact Michael Ibsen, MD
Phone + 45 45 35 94 18
Email micibs@dadlnet.dk
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Rectal biopsy
Rectal biopsy.
Measurement of inflammatory markers in the rectal mucosa
IL-6, TNF-alfa.
Measurement of rectal lactic acid
Equilibrium dialysis.

Locations

Country Name City State
Denmark Dept. of Intensive Care 4131 Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

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