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Clinical Trials/NCT00332267
NCT00332267
Completed
Not Applicable

Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

Rigshospitalet, Denmark1 site in 1 country36 target enrollmentMay 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypoxia
Sponsor
Rigshospitalet, Denmark
Enrollment
36
Locations
1
Primary Endpoint
Cerebral blood flow
Status
Completed
Last Updated
17 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 2006
End Date
July 2006
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • Healthy nonsmoking male
  • Age 18-45 yrs

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cerebral blood flow

Time Frame: 0, 9 hours

Cerebral oxygen metabolism

Time Frame: 0, 9 hours

Plasma cytokine content

Time Frame: 0, 4, 19, 12 hours

Lake Louise Score

Time Frame: 0, 4, 9, 12 hours

ESQ-C

Time Frame: 0, 4, 9, 12 hours

Endotoxemia Score

Time Frame: 0, 4, 9, 12 hours

Secondary Outcomes

  • Cerebral net flux(0, 9 hours)
  • Mean arterial pressure(Hourly, 0 through 12 hours)
  • Heart rate(Hourly, 0 through 12 hours)
  • Oxygen saturation(Hourly, 0 through 12 hours)
  • Body temperature(Hourly, 0 through 12 hours)

Study Sites (1)

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