Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

Healthy Clinical Trial

Official title:

Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332267
• Other study ID #: KM-HYP/ETX
• Status: Completed
• Phase: N/A
• First received: May 31, 2006
• Last updated: September 2, 2008
• Start date: May 2006
• Est. completion date: July 2006

Study information

• Verified date: September 2008
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy nonsmoking male

• Age 18-45 yrs

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endotoxemia
• Healthy
• Hypoxia

Intervention

Procedure:
• Endotoxin infusion, Normobaric hypoxia

Locations

Country	Name	City	State
Denmark	Center of Inflammation and Metabolism, Rigshospitalet	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	H:S, Denmark, The Danish National Research Foundation, Denmark, The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral blood flow		0, 9 hours	No
Primary	Cerebral oxygen metabolism		0, 9 hours	No
Primary	Plasma cytokine content		0, 4, 19, 12 hours	No
Primary	Lake Louise Score		0, 4, 9, 12 hours	No
Primary	ESQ-C		0, 4, 9, 12 hours	No
Primary	Endotoxemia Score		0, 4, 9, 12 hours	No
Secondary	Cerebral net flux		0, 9 hours	No
Secondary	Mean arterial pressure		Hourly, 0 through 12 hours	No
Secondary	Heart rate		Hourly, 0 through 12 hours	No
Secondary	Oxygen saturation		Hourly, 0 through 12 hours	Yes
Secondary	Body temperature		Hourly, 0 through 12 hours	No