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Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

Primary Purpose

Hypoxia, Endotoxemia, Healthy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Endotoxin infusion, Normobaric hypoxia
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoxia focused on measuring Sepsis, Hypoxia, Altitude Sickness, Endotoxin, Cytokines, Cerebral blood flow, Cerebral metabolism, Reactive oxygen species

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy nonsmoking male Age 18-45 yrs Exclusion Criteria:

Sites / Locations

  • Center of Inflammation and Metabolism, Rigshospitalet

Outcomes

Primary Outcome Measures

Cerebral blood flow
Cerebral oxygen metabolism
Plasma cytokine content
Lake Louise Score
ESQ-C
Endotoxemia Score

Secondary Outcome Measures

Cerebral net flux
Mean arterial pressure
Heart rate
Oxygen saturation
Body temperature

Full Information

First Posted
May 31, 2006
Last Updated
September 2, 2008
Sponsor
Rigshospitalet, Denmark
Collaborators
The Ministry of Science, Technology and Innovation, Denmark, H:S, Denmark, The Danish National Research Foundation, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00332267
Brief Title
Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia
Official Title
Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
The Ministry of Science, Technology and Innovation, Denmark, H:S, Denmark, The Danish National Research Foundation, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Endotoxemia, Healthy
Keywords
Sepsis, Hypoxia, Altitude Sickness, Endotoxin, Cytokines, Cerebral blood flow, Cerebral metabolism, Reactive oxygen species

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Endotoxin infusion, Normobaric hypoxia
Primary Outcome Measure Information:
Title
Cerebral blood flow
Time Frame
0, 9 hours
Title
Cerebral oxygen metabolism
Time Frame
0, 9 hours
Title
Plasma cytokine content
Time Frame
0, 4, 19, 12 hours
Title
Lake Louise Score
Time Frame
0, 4, 9, 12 hours
Title
ESQ-C
Time Frame
0, 4, 9, 12 hours
Title
Endotoxemia Score
Time Frame
0, 4, 9, 12 hours
Secondary Outcome Measure Information:
Title
Cerebral net flux
Time Frame
0, 9 hours
Title
Mean arterial pressure
Time Frame
Hourly, 0 through 12 hours
Title
Heart rate
Time Frame
Hourly, 0 through 12 hours
Title
Oxygen saturation
Time Frame
Hourly, 0 through 12 hours
Title
Body temperature
Time Frame
Hourly, 0 through 12 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy nonsmoking male Age 18-45 yrs Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Taudorf, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirsten Moller, MD, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Inflammation and Metabolism, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark

12. IPD Sharing Statement

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Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

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