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HypoxiaNCT00332267

Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia

A study testing Endotoxin infusion, Normobaric hypoxia in people with Hypoxia and Endotoxemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Hypoxia, Endotoxemia, Healthy
What is being tested?
Endotoxin infusion, Normobaric hypoxia
How many people
36 participants
Where
1 siteDenmark
Study dates
May 2006to Jul 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy nonsmoking male
  • Age 18-45 yrs

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Center of Inflammation and Metabolism, Rigshospitalet

    Copenhagen, DK-2100

Other trials in Denmark

About this study

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.

Read the 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).

Being tested
Endotoxin infusion, Normobaric hypoxia
Keywords
Sepsis, Hypoxia, Altitude Sickness, Endotoxin, Cytokines, Cerebral blood flow, Cerebral metabolism, Reactive oxygen species
Medical subject headings
Hypoxia, Endotoxemia, Sepsis, Altitude Sickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endotoxin infusion, Normobaric hypoxiaProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cerebral blood flow

    Measured: 0, 9 hours

  2. Cerebral oxygen metabolism

    Measured: 0, 9 hours

  3. Plasma cytokine content

    Measured: 0, 4, 19, 12 hours

  4. Lake Louise Score

    Measured: 0, 4, 9, 12 hours

  5. ESQ-C

    Measured: 0, 4, 9, 12 hours

  6. Endotoxemia Score

    Measured: 0, 4, 9, 12 hours

Secondary outcomes (5)

  1. Cerebral net flux

    Measured: 0, 9 hours

  2. Mean arterial pressure

    Measured: Hourly, 0 through 12 hours

  3. Heart rate

    Measured: Hourly, 0 through 12 hours

  4. Oxygen saturation

    Measured: Hourly, 0 through 12 hours

  5. Body temperature

    Measured: Hourly, 0 through 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJul 2006
  4. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00332267
Sponsor's protocol ID
KM-HYP/ETX
Status last verified
Sep 2008
First submitted
31 May 2006
Last updated
4 Sep 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Endotoxin infusion, Normobaric hypoxia in people with Hypoxia and Endotoxemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cerebral blood flow (time frame: 0, 9 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00332267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2008.

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