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Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00332267
First Posted: June 1, 2006
Last Update Posted: September 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
H:S, Denmark
The Danish National Research Foundation, Denmark
Information provided by:
Rigshospitalet, Denmark
  Purpose
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 Intervention
Hypoxia Endotoxemia Healthy Procedure: Endotoxin infusion, Normobaric hypoxia

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: May 2006
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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).
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy nonsmoking male
  • Age 18-45 yrs

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Denmark
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
Investigators
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 Submitted: May 31, 2006
First Posted: June 1, 2006
Last Update Posted: September 4, 2008
Last Verified: September 2008

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

Additional relevant MeSH terms:
Anoxia
Endotoxemia
Signs and Symptoms, Respiratory
Signs and Symptoms
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes