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Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00332267
Enrollment
36
Registered
2006-06-01
Start date
2006-05-31
Completion date
2006-07-31
Last updated
2008-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotoxemia, Healthy, Hypoxia

Keywords

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

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 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).

Interventions

PROCEDUREEndotoxin infusion, Normobaric hypoxia

Sponsors

The Ministry of Science, Technology and Innovation, Denmark
CollaboratorOTHER_GOV
H:S, Denmark
CollaboratorUNKNOWN
The Danish National Research Foundation, Denmark
CollaboratorUNKNOWN
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy nonsmoking male * Age 18-45 yrs

Design outcomes

Primary

MeasureTime frame
Endotoxemia Score0, 4, 9, 12 hours
Cerebral blood flow0, 9 hours
Cerebral oxygen metabolism0, 9 hours
Plasma cytokine content0, 4, 19, 12 hours
Lake Louise Score0, 4, 9, 12 hours
ESQ-C0, 4, 9, 12 hours

Secondary

MeasureTime frame
Mean arterial pressureHourly, 0 through 12 hours
Heart rateHourly, 0 through 12 hours
Oxygen saturationHourly, 0 through 12 hours
Body temperatureHourly, 0 through 12 hours
Cerebral net flux0, 9 hours

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026