Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Hypoxia; Endotoxemia
• Intervention / Treatment: Procedure: Endotoxin infusion, Normobaric hypoxia

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2100
    • Center of Inflammation and Metabolism, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy nonsmoking male
• Age 18-45 yrs

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: May 31, 2006
• First Submitted That Met QC Criteria: May 31, 2006
• First Posted (Estimate): June 1, 2006

Study Record Updates

• Last Update Posted (Estimate): September 4, 2008
• Last Update Submitted That Met QC Criteria: September 2, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Endotoxin; Hypoxia; Sepsis; Cytokines; Cerebral blood flow; Altitude Sickness; Reactive oxygen species; Cerebral metabolism
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Signs and Symptoms, Respiratory; Bacteremia; Toxemia; Endotoxemia; Hypoxia
• Other Study ID Numbers: KM-HYP/ETX