Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

Not Applicable

Completed

• Conditions: Hypoxia; Endotoxemia; Healthy

• Registration Number: NCT00332267
• Lead Sponsor: Rigshospitalet, Denmark

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).

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-31
• Study First Submitted QC: 2006-05-31
• Study First Posted: 2006-06-01
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-02
• Last Update Posted: 2008-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• Healthy nonsmoking male
• Age 18-45 yrs

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cerebral blood flow	0, 9 hours
Cerebral oxygen metabolism	0, 9 hours
Plasma cytokine content	0, 4, 19, 12 hours
Lake Louise Score	0, 4, 9, 12 hours
ESQ-C	0, 4, 9, 12 hours
Endotoxemia Score	0, 4, 9, 12 hours

Secondary Outcome Measures

Name	Time	Method
Cerebral net flux	0, 9 hours
Mean arterial pressure	Hourly, 0 through 12 hours
Heart rate	Hourly, 0 through 12 hours
Oxygen saturation	Hourly, 0 through 12 hours
Body temperature	Hourly, 0 through 12 hours

Trial Locations

Locations (1)

Center of Inflammation and Metabolism, Rigshospitalet; 🇩🇰 Copenhagen, Denmark