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Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

This study has been completed.
Sponsor:
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
H:S, Denmark
The Danish National Research Foundation, Denmark
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00332267
First received: May 31, 2006
Last updated: September 2, 2008
Last verified: September 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Cerebral blood flow [ Time Frame: 0, 9 hours ] [ Designated as safety issue: No ]
  • Cerebral oxygen metabolism [ Time Frame: 0, 9 hours ] [ Designated as safety issue: No ]
  • Plasma cytokine content [ Time Frame: 0, 4, 19, 12 hours ] [ Designated as safety issue: No ]
  • Lake Louise Score [ Time Frame: 0, 4, 9, 12 hours ] [ Designated as safety issue: No ]
  • ESQ-C [ Time Frame: 0, 4, 9, 12 hours ] [ Designated as safety issue: No ]
  • Endotoxemia Score [ Time Frame: 0, 4, 9, 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cerebral net flux [ Time Frame: 0, 9 hours ] [ Designated as safety issue: No ]
  • Mean arterial pressure [ Time Frame: Hourly, 0 through 12 hours ] [ Designated as safety issue: No ]
  • Heart rate [ Time Frame: Hourly, 0 through 12 hours ] [ Designated as safety issue: No ]
  • Oxygen saturation [ Time Frame: Hourly, 0 through 12 hours ] [ Designated as safety issue: Yes ]
  • Body temperature [ Time Frame: Hourly, 0 through 12 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy nonsmoking male
  • Age 18-45 yrs

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kirsten Moller, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00332267     History of Changes
Other Study ID Numbers: KM-HYP/ETX
Study First Received: May 31, 2006
Last Updated: September 2, 2008
Health Authority: Denmark: National Board of Health

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

ClinicalTrials.gov processed this record on May 21, 2013