Hemodynamic Changes in Altitude Adaptation

Acute Mountain Sickness Clinical Trial

Official title:

Hemodynamic Changes in Altitude Adaptation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01698619
• Other study ID #: AconcaguaIron
• Status: Recruiting
• Phase: N/A
• First received: September 27, 2012
• Last updated: October 2, 2012
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: September 2012
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness
• Brain Edema
• Edema
• High Altitude Cerebral Edema
• High Altitude Pulmonary Edema
• Hypertension, Pulmonary
• Pulmonary Edema

Locations

Country	Name	City	State
Germany	Goethe University	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes from baseline in Blood pressure, Fluid Responsiveness, Oxygen Saturation, Cardiac Output	baseline measure will be obtained at sea level	daily, up to 18 days	Yes
Primary	Changes from baseline in Oxygen Delivery	Unit: ml/min baseline measure will be obtained at sea level	daily, up to 18 days	Yes
Secondary	Changes from baseline in Hemoglobin Concentration	Unit: mg/dl baseline measure will be obtained at sea level	daily, up to 18 days	Yes