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Hemodynamic Changes in Altitude Adaptation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Peter Stein, Goethe University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01698619
First Posted: October 3, 2012
Last Update Posted: October 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter Stein, Goethe University
  Purpose
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.

Condition
Acute Mountain Sickness High Altitude Pulmonary Edema High Altitude Cerebral Edema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemodynamic Changes in Altitude Adaptation

Resource links provided by NLM:


Further study details as provided by Peter Stein, Goethe University:

Primary Outcome Measures:
  • Changes from baseline in Oxygen Delivery [ Time Frame: daily, up to 18 days ]
    Unit: ml/min baseline measure will be obtained at sea level


Secondary Outcome Measures:
  • Changes from baseline in Hemoglobin Concentration [ Time Frame: daily, up to 18 days ]
    Unit: mg/dl baseline measure will be obtained at sea level


Other Outcome Measures:
  • Changes from baseline in Blood pressure, Fluid Responsiveness, Oxygen Saturation, Cardiac Output [ Time Frame: daily, up to 18 days ]
    baseline measure will be obtained at sea level


Estimated Enrollment: 12
Study Start Date: August 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Climbers on Mount Aconcagua
The Cohort consists of volunteers climbing 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers taking part in an expedition to Mount Aconcagua
Criteria

Inclusion Criteria:

  • No acute or chronic disease
  • Body mass index : 20 - 30

Exclusion Criteria:

  • Any preexisting disease that has a potential impact on physical performance such as:

    • pulmonary
    • cerebral
    • muscular
    • cardiac
    • vascular - diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698619


Locations
Germany
Goethe University Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Peter Stein, Dr.    0049 1577 6400 769    peter.stein@kgu.de   
Sponsors and Collaborators
Goethe University
  More Information

Responsible Party: Peter Stein, Consultant, Goethe University
ClinicalTrials.gov Identifier: NCT01698619     History of Changes
Other Study ID Numbers: AconcaguaIron
First Submitted: September 27, 2012
First Posted: October 3, 2012
Last Update Posted: October 3, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Edema
Altitude Sickness
Pulmonary Edema
Brain Edema
Hypertension, Pulmonary
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases