Hemodynamic Changes in Altitude Adaptation

October 2, 2012 updated by: Peter Stein, Goethe University
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Recruiting
        • Goethe University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy volunteers taking part in an expedition to Mount Aconcagua

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Climbers on Mount Aconcagua
The Cohort consists of volunteers climbing Mount Aconcagua.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in Oxygen Delivery
Time Frame: daily, up to 18 days
Unit: ml/min baseline measure will be obtained at sea level
daily, up to 18 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in Hemoglobin Concentration
Time Frame: daily, up to 18 days
Unit: mg/dl baseline measure will be obtained at sea level
daily, up to 18 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
daily, up to 18 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Estimate)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AconcaguaIron

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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