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Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

NCT ID: NCT00332267

Last Updated: 2008-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-07-31

Brief Summary

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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

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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).

Conditions

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Hypoxia Endotoxemia Healthy

Keywords

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Sepsis Hypoxia Altitude Sickness Endotoxin Cytokines Cerebral blood flow Cerebral metabolism Reactive oxygen species

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Endotoxin infusion, Normobaric hypoxia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy nonsmoking male
* Age 18-45 yrs
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Ministry of Science, Technology and Innovation, Denmark

OTHER_GOV

Sponsor Role collaborator

H:S, Denmark

UNKNOWN

Sponsor Role collaborator

The Danish National Research Foundation, Denmark

UNKNOWN

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Rigshospitalet

Principal Investigators

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Sarah Taudorf, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Kirsten Moller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Center of Inflammation and Metabolism, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KM-HYP/ETX

Identifier Type: -

Identifier Source: org_study_id