Acute Mountain SicknessNCT01698619
Hemodynamic Changes in Altitude Adaptation
An observational study of Acute Mountain Sickness and High Altitude Pulmonary Edema, run by Goethe University at 1 site in Germany.
Trial summary
We use a new technology (Nexfin from BMEYE-Inventive Hemodynamics) to monitor Cardiac Output, Blood Pressure, Fluid Responsiveness, Pulse Oximetry, Hemoglobin Concentration, Oxygen Delivery in Climbers during their process of acclimatization on a expedition to Mount Aconcagua. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness, High Altitude Pulmonary Edema, High Altitude Cerebral Edema
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Dec 2012
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy volunteers taking part in an expedition to Mount Aconcagua
Who may be able to join
- No acute or chronic disease
- Body mass index : 20 - 30
Who cannot join
- Any preexisting disease that has a potential impact on physical performance such as:
- pulmonary
- cerebral
- muscular
- cardiac
- vascular - diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Goethe University
Frankfurt am Main, Hesse, 60590
Peter Stein, Dr., 0049 1577 6400 769, peter.stein@kgu.de
About this study
We use a new technology (Nexfin from BMEYE-Inventive Hemodynamics) to monitor Cardiac Output, Blood Pressure, Fluid Responsiveness, Pulse Oximetry, Hemoglobin Concentration, Oxygen Delivery in Climbers during their process of acclimatization on a expedition to Mount Aconcagua.
Read the detailed description
Several parameters will be recorded to analyze their influence on the adaptation to high altitude. Such as, food composition, dietary supplements, water intake and output.
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Climbers on Mount Aconcagua | The Cohort consists of volunteers climbing Mount Aconcagua. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Oxygen Delivery
Unit: ml/min baseline measure will be obtained at sea level
Measured: daily, up to 18 days
Secondary outcomes (1)
Changes from baseline in Hemoglobin Concentration
Unit: mg/dl baseline measure will be obtained at sea level
Measured: daily, up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mountain SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Stein, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698619
- Sponsor's protocol ID
- AconcaguaIron
- Status last verified
- Sep 2012
- First submitted
- 27 Sep 2012
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes in Altitude Adaptation
- ClinicalTrials.gov ID
- NCT01698619
- Acronym / sponsor ID
- AconcaguaIron
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We use a new technology (Nexfin from BMEYE-Inventive Hemodynamics) to monitor Cardiac Output, Blood Pressure, Fluid Responsiveness, Pulse Oximetry, Hemoglobin Concentration, Oxygen Delivery in Climbers during their process of acclimatization on a expedition to Mount Aconcagua.
Detailed description
Several parameters will be recorded to analyze their influence on the adaptation to high altitude. Such as, food composition, dietary supplements, water intake and output.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Climbers on Mount Aconcagua | – | –The Cohort consists of volunteers climbing Mount Aconcagua. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteers taking part in an expedition to Mount Aconcagua
Key inclusion criteria (2 listed)
- No acute or chronic disease
- Body mass index : 20 - 30
Key exclusion criteria (6 listed)
- Any preexisting disease that has a potential impact on physical performance such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes from baseline in Oxygen Delivery
Time frame: daily, up to 18 days
Unit: ml/min baseline measure will be obtained at sea level
1 secondary outcome
Changes from baseline in Hemoglobin Concentration
Time frame: daily, up to 18 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Mountain Sickness and High Altitude Pulmonary Edema, run by Goethe University at 1 site in Germany.
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 6 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: status not confirmed, as of the sponsor's last update on 3 Oct 2012. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in Oxygen Delivery (time frame: daily, up to 18 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2012.