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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
Information provided by (Responsible Party):
Peter Stein, Goethe University Identifier:
First received: September 27, 2012
Last updated: October 2, 2012
Last verified: September 2012
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.

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)
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01698619

Goethe University Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Peter Stein, Dr.    0049 1577 6400 769   
Sponsors and Collaborators
Goethe University
  More Information

Responsible Party: Peter Stein, Consultant, Goethe University Identifier: NCT01698619     History of Changes
Other Study ID Numbers: AconcaguaIron
Study First Received: September 27, 2012
Last Updated: October 2, 2012

Additional relevant MeSH terms:
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 processed this record on August 17, 2017