High Altitude Medical Research Expedition Himlung 2013 - a Study of Human Adaption to Hypoxia

NCT01953198 | Completed

• 1 other identifier: 226/12
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the project "High Altitude Medical Research Expedition Himlung 2013" (HiReach2013) is to comprehensively investigate the cerebral, cardiovascular and pulmonary adaptation and the reactions of the human immune system during an ascent to extreme altitudes of over 7000 m. A total of 44 healthy and trained volunteers will be included in the study after written informed consent has been obtained.Baseline sea level clinical examination will be performed in Bern, Switzerland (BE1) at 550 m 8 to 4 weeks before departure. High altitude research facilities will be available at the altitudes of 5000m, 6100m and 6900m. Post-expedition examination will be performed within 2 to 6 weeks after the end of the expedition in Bern. In the context of 3 sub-projects specific measurements and examinations are performed. These include: cMRI before and after the climb and neurovascular doppler examination during the climb; blood sampling for coagulation studies, cardiac and thoracic ultrasound, stress tests for assessment of cardiovascular performance.

Conditions

Hypoxia

Keywords

hypoxia hypobaric

Outcome Measures

Primary Outcomes (1)

• Pulmonary adaption to hypoxia

  Time of reaching 4 different altitudes, expected to be after 1 month

Secondary Outcomes (3)

• Cerebral adaption to hypoxia

  Time of reaching 4 different altitudes, expected to be after 1 month

• Cardiovascular adaption to hypoxia

  Time of reaching 4 different altitudes, expected to be after 1 month

• Adaption of the coagulation system

  Time of reaching 4 different altitudes, expected to be after 1 month

Study Arms (1)

All study participants

A total of 44 healthy and trained volunteers, age between 18 and 70 years. Subjects must have basic mountaineering experience.

Other: Hypobaric hypoxia

Interventions

Hypobaric hypoxia OTHER

Subjects are exposed to hypobaric hypoxia in the context of a high altitude expedition.

All study participants

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy and trained volunteers with basic mountaineering experience

You may qualify if:

• Subjects must be healthy, well trained and have basic mountaineering experience
• Written informed consent

You may not qualify if:

• Subjects with any type of cardiac and or respiratory disease
• Subjects with diabetes mellitus type I or II
• Regular intake of beta-blockers, ACE-inhibitors, nitrates and calcium antagonists as well as corticosteroids or anti-inflammatory medication
• Subjects who developed high altitude pulmonary edema after a rapid ascent (\< 3 nights) at altitudes below 3500m
• Subjects who developed severe acute mountain sickness and/or high altitude cerebral edema after rapid ascent to altitudes below 3500m

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Departement of Intensive Care Medicine

Bern, 3013, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum urine

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tobias M Merz, MD

  Department of Intensive Care Medicine, University Hospital Bern, Switerzland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: September 30, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 30, 2013

Record last verified: 2013-09

Locations

CH (1)