Hemodynamic Changes in Altitude Adaptation

• Conditions: Acute Mountain Sickness; High Altitude Pulmonary Edema; High Altitude Cerebral Edema

• Registration Number: NCT01698619
• Lead Sponsor: Goethe University

Brief 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.

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 Timeline

• Study Start: 2012-08
• Status Verified: 2012-09
• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-10-02
• Last Update Submitted: 2012-10-02
• Study First Posted: 2012-10-03
• Last Update Posted: 2012-10-03
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Goethe University; 🇩🇪 Frankfurt, Hessen, Germany