Clinical Trial: Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

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 Summary: 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).
Sponsor: Rigshospitalet, Denmark

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

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


Current Secondary Outcome:

  • Cerebral net flux [ Time Frame: 0, 9 hours ]
  • Mean arterial pressure [ Time Frame: Hourly, 0 through 12 hours ]
  • Heart rate [ Time Frame: Hourly, 0 through 12 hours ]
  • Oxygen saturation [ Time Frame: Hourly, 0 through 12 hours ]
  • Body temperature [ Time Frame: Hourly, 0 through 12 hours ]


Original Secondary Outcome:

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


Information By: Rigshospitalet, Denmark

Dates:
Date Received: May 31, 2006
Date Started: May 2006
Date Completion:
Last Updated: September 2, 2008
Last Verified: September 2008