Healthy Clinical Trial
Official title:
Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia
Verified date | September 2008 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: National Board of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | July 2006 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Healthy nonsmoking male - Age 18-45 yrs Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Denmark | Center of Inflammation and Metabolism, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | H:S, Denmark, The Danish National Research Foundation, Denmark, The Ministry of Science, Technology and Innovation, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cerebral blood flow | 0, 9 hours | No | |
Primary | Cerebral oxygen metabolism | 0, 9 hours | No | |
Primary | Plasma cytokine content | 0, 4, 19, 12 hours | No | |
Primary | Lake Louise Score | 0, 4, 9, 12 hours | No | |
Primary | ESQ-C | 0, 4, 9, 12 hours | No | |
Primary | Endotoxemia Score | 0, 4, 9, 12 hours | No | |
Secondary | Cerebral net flux | 0, 9 hours | No | |
Secondary | Mean arterial pressure | Hourly, 0 through 12 hours | No | |
Secondary | Heart rate | Hourly, 0 through 12 hours | No | |
Secondary | Oxygen saturation | Hourly, 0 through 12 hours | Yes | |
Secondary | Body temperature | Hourly, 0 through 12 hours | No |
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