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NCT00197938 Clinical Trial

Lactic Acid in the Rectum and Life-Threatening Infection

Septic Shock Clinical Trial

Official title:
Does the Concentration of L-Lactate in the Rectum Correlate With Mortality and Morbidity in Patients With Septic Shock?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00197938
Other study ID # KA 05091m
Secondary ID
Status Completed
Phase N/A
First received September 14, 2005
Last updated June 5, 2009
Start date November 2005
Est. completion date April 2009

Study information
Verified date June 2009
Source Herlev Hospital
Contact n/a
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 lactic acid.

The investigators hypothesize, that the more serious the condition, the higher the concentration of lactic acid will be, thus relating to the risk of multiple organ failure or death.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date April 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Fluid resuscitated septic shock < 24 h.

Exclusion Criteria:

- Septic shock > 24 h.

- Pathology in the rectum.

- Bleeding per rectum.

- Limitation of therapy.

- Where informed consent from relatives cannot be obtained.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Measurement of rectal lactic acid.

Locations
Country Name City State
Denmark Dept. of Intensive Care 4131, Rigshospitalet Copenhagen
Denmark Dept. of Intensive Care, Glostrup University Hospital Glostrup
Denmark Dept. of Intensive Care, Gentofte University Hospital Hellerup
Denmark Dept. of Intensive Care, Herlev University Hospital Herlev
Finland Dept. of Intensive Care, Tampere University Hospital Tampere

Sponsors (1)
Lead Sponsor Collaborator
Herlev Hospital

Countries where clinical trial is conducted

Denmark,  Finland, 

See also
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