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Sponsors and Collaborators: |
Rigshospitalet, Denmark The Ministry of Science, Technology and Innovation, Denmark H:S, Denmark The Danish National Research Foundation, Denmark |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00332267 |
The objective of the present protocol is to study whether a low level of oxygen in the blood will affect the immune response to as well as cerebral blood flow and metabolism during an infection and, conversely, whether the acute systemic and cerebral physiologic response to hypoxia is modified by an ongoing inflammatory response.
Condition | Intervention |
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Hypoxia Endotoxemia Healthy |
Procedure: Endotoxin infusion, Normobaric hypoxia |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia |
Enrollment: | 36 |
Study Start Date: | May 2006 |
Study Completion Date: | July 2006 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
The combination of acute infection and a low level of oxygen in the blood is a common phenomenon. Thus, acute hypoxia may complicate severe infections including severe sepsis. Conversely, healthy persons who ascend to moderately high altitudes, which will be associated with a lowering of the inspired oxygen level, may sustain an infection. Even so, it is unknown whether hypoxia modifies the systemic inflammatory response, or, conversely, whether the reaction to hypoxia is influenced by the presence of systemic inflammation. The present protocol aims to measure global cerebral blood flow, metabolism and net flux as well as the systemic response in healthy volunteers who are subjected to either normobaric hypoxia alone (N=12), low-dose IV endotoxin infusion alone (N=12), or a combination of endotoxin infusion and normobaric hypoxia (N=12).
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Denmark, - | |
Center of Inflammation and Metabolism, Rigshospitalet | |
Copenhagen, -, Denmark, DK-2100 |
Principal Investigator: | Sarah Taudorf, MD | Rigshospitalet, Denmark |
Principal Investigator: | Kirsten Moller, MD, PhD | Rigshospitalet, Denmark |
Responsible Party: | Rigshospitalet ( Kirsten Moller ) |
Study ID Numbers: | KM-HYP/ETX |
Study First Received: | May 31, 2006 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00332267 |
Health Authority: | Denmark: National Board of Health |
Sepsis Hypoxia Altitude Sickness Endotoxin |
Cytokines Cerebral blood flow Cerebral metabolism Reactive oxygen species |
Systemic Inflammatory Response Syndrome Signs and Symptoms Altitude Sickness Sepsis Acute mountain sickness Bacteremia |
Signs and Symptoms, Respiratory Endotoxemia Healthy Toxemia Inflammation Anoxia |
Pathologic Processes Infection |