Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia - Full Text View

Sponsors and Collaborators:	Rigshospitalet, Denmark 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

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

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

Responsible Party:	Rigshospitalet ( Kirsten Moller )
Study ID Numbers:	KM-HYP/ETX
Study First Received:	May 31, 2006
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00332267
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

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Signs and Symptoms
Altitude Sickness
Sepsis
Acute mountain sickness
Bacteremia

Signs and Symptoms, Respiratory
Endotoxemia
Healthy
Toxemia
Inflammation
Anoxia

Additional relevant MeSH terms:

Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009