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Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

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ClinicalTrials.gov Identifier: NCT00332267
Recruitment Status : Completed
First Posted : June 1, 2006
Last Update Posted : September 4, 2008
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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.

Condition or disease Intervention/treatment
Hypoxia Endotoxemia Healthy Procedure: Endotoxin infusion, Normobaric hypoxia

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia
Study Start Date : May 2006
Primary Completion Date : July 2006
Study Completion Date : July 2006

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U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Cerebral blood flow [ Time Frame: 0, 9 hours ]
  2. Cerebral oxygen metabolism [ Time Frame: 0, 9 hours ]
  3. Plasma cytokine content [ Time Frame: 0, 4, 19, 12 hours ]
  4. Lake Louise Score [ Time Frame: 0, 4, 9, 12 hours ]
  5. ESQ-C [ Time Frame: 0, 4, 9, 12 hours ]
  6. Endotoxemia Score [ Time Frame: 0, 4, 9, 12 hours ]

Secondary Outcome Measures :
  1. Cerebral net flux [ Time Frame: 0, 9 hours ]
  2. Mean arterial pressure [ Time Frame: Hourly, 0 through 12 hours ]
  3. Heart rate [ Time Frame: Hourly, 0 through 12 hours ]
  4. Oxygen saturation [ Time Frame: Hourly, 0 through 12 hours ]
  5. Body temperature [ Time Frame: Hourly, 0 through 12 hours ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy nonsmoking male
  • Age 18-45 yrs

Exclusion Criteria:

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332267

Center of Inflammation and Metabolism, Rigshospitalet
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
The Ministry of Science, Technology and Innovation, Denmark
H:S, Denmark
The Danish National Research Foundation, Denmark
Principal Investigator: Sarah Taudorf, MD Rigshospitalet, Denmark
Principal Investigator: Kirsten Moller, MD, PhD Rigshospitalet, Denmark
More Information

Responsible Party: Kirsten Moller, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00332267     History of Changes
Other Study ID Numbers: KM-HYP/ETX
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: September 4, 2008
Last Verified: September 2008

Keywords provided by Rigshospitalet, Denmark:
Altitude Sickness
Cerebral blood flow
Cerebral metabolism
Reactive oxygen species

Additional relevant MeSH terms:
Signs and Symptoms, Respiratory
Signs and Symptoms
Systemic Inflammatory Response Syndrome
Pathologic Processes