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Hemodynamic Changes in Altitude Adaptation

This study is currently recruiting participants.
Verified September 2012 by Goethe University
Sponsor:
Information provided by (Responsible Party):
Peter Stein, Goethe University
ClinicalTrials.gov Identifier:
NCT01698619
First received: September 27, 2012
Last updated: October 2, 2012
Last verified: September 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Goethe University:

Primary Outcome Measures:
  • Changes from baseline in Oxygen Delivery [ Time Frame: daily, up to 18 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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

ClinicalTrials.gov processed this record on June 17, 2013