- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00197938
Lactic Acid in the Rectum and Life-Threatening Infection
June 5, 2009 updated by: Herlev Hospital
Does the Concentration of L-Lactate in the Rectum Correlate With Mortality and Morbidity in Patients With Septic Shock?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, DK-2100
- Dept. of Intensive Care 4131, Rigshospitalet
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Glostrup, Denmark, DK-2600
- Dept. of Intensive Care, Glostrup University Hospital
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Hellerup, Denmark, DK-2900
- Dept. of Intensive Care, Gentofte University Hospital
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Herlev, Denmark, DK-2730
- Dept. of Intensive Care, Herlev University Hospital
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Tampere, Finland, 33521
- Dept. of Intensive Care, Tampere University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients with early septic shock (< 24 h).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Anders Perner, MD, PhD, Dept. of Anaesthesia and Intensive Care, Herlev University Hospital, DK-2730 Herlev
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Completion (ACTUAL)
April 1, 2009
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (ESTIMATE)
September 20, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
June 9, 2009
Last Update Submitted That Met QC Criteria
June 5, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA 05091m
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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