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Completed

NCT Number: NCT00332267

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.

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Key information

Conditions

Hypoxia Altitude Sickness Bacteremia Endotoxemia Healthy Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sepsis Signs and Symptoms Signs and Symptoms, Respiratory Systemic Inflammatory Response Syndrome Toxemia

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center of Inflammation and Metabolism, Rigshospitalet

Copenhagen, DK-2100, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy nonsmoking male
  • Age 18-45 yrs

Exclusion criteria

Treatment and study plan

Endotoxin infusion, Normobaric hypoxia

Procedure

Primary outcomes

  1. Cerebral blood flow

    Time frame: 0, 9 hours

  2. Cerebral oxygen metabolism

    Time frame: 0, 9 hours

  3. Plasma cytokine content

    Time frame: 0, 4, 19, 12 hours

  4. Lake Louise Score

    Time frame: 0, 4, 9, 12 hours

  5. ESQ-C

    Time frame: 0, 4, 9, 12 hours

  6. Endotoxemia Score

    Time frame: 0, 4, 9, 12 hours

Secondary outcomes

  1. Cerebral net flux

    Time frame: 0, 9 hours

  2. Mean arterial pressure

    Time frame: Hourly, 0 through 12 hours

  3. Heart rate

    Time frame: Hourly, 0 through 12 hours

  4. Oxygen saturation

    Time frame: Hourly, 0 through 12 hours

  5. Body temperature

    Time frame: Hourly, 0 through 12 hours

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • H:S, Denmark
  • The Danish National Research Foundation, Denmark
  • The Ministry of Science, Technology and Innovation, Denmark

Registry information

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jun 1, 2006
Registry last updated
Sep 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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