Intravascular Volumes in Hypoxia During Antarctic Confinement

NCT04106401 | Unknown

• 1 other identifier: 2018-A03243-52
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of hypoxia on blood volumes during Antarctic winter-over confinement. Half of the participants will be evaluated during sea-level winter-over confinement, while the other half will be examined during high-altitude hypoxia winter-over confinement.

Conditions

Hypoxia; Confinement

Keywords

total red blood cell volume; plasma volume; total hemoglobin mass; total blood volume

Outcome Measures

Primary Outcomes (4)

• total hemoglobin mass

  Physiological parameter, corresponding to the total amount of circulating hemoglobin, expressed in grams, and determined with the 10-min carbon-monoxide rebreathing method and blood carboxyhemoglobin measurements (expressed in %).

  15 months

• total red blood cell volume

  Physiological parameter, corresponding to the total volume of circulating red blood cells, expressed in liters, and derived from total hemoglobin mass, hematocrit (expressed in fraction) and hemoglobin concentration (expressed in gram per deciliter).

  15 months

• total blood volume

  Physiological parameter, corresponding the the total volume of blood, expressed in liters, and derived from total red blood cell volume and hematocrit.

  15 months

• plasma volume

  Physiological parameter, corresponding to the total volume of plasma, expressed in liters, and derived from total blood volume and total red blood cell volume.

  15 months

Secondary Outcomes (11)

• blood viscosity

  15 months

• serum erythropoietin

  15 months

• serum hepcidin

  15 months

• serum erythroferrone

  15 months

• serum transferrin saturation

  15 months

Study Arms (2)

hypoxia & confinement

EXPERIMENTAL

Participants exposed to high-altitude hypoxia and confinement during a one-year stay at Concordia station, Antarctica (3200 m)

Other: carbon-monoxide rebreathing; Other: venous blood sampling; Other: physical activity monitoring; Other: apnea-hypopnea index and nocturnal oxygenation; Other: 24-hour blood pressure

confinement

ACTIVE COMPARATOR

Participants exposed to confinement during a one-year stay at Dumont d'Urville station, Antarctica (sea level)

Other: carbon-monoxide rebreathing; Other: venous blood sampling; Other: physical activity monitoring; Other: apnea-hypopnea index and nocturnal oxygenation; Other: 24-hour blood pressure

Interventions

carbon-monoxide rebreathing OTHER

Inhaled carbon monoxide (CO) administrated as a bolus into a rebreathing circuit serves as a marker to tag circulating hemoglobin molecules and to calculate total hemoglobin mass (Hbmass). The change in blood CO concentration from pre- to postadministration (delta carboxyhemoglobin concentration) and the dose of administrated CO allows for Hbmass determination. The other blood compartments (total red blood cell volume, plasma volume and total blood volume) are derived from Hbmass, hematocrit and/or hemoglobin concentration.

confinement; hypoxia & confinement

venous blood sampling OTHER

venous blood sampling at rest to evaluate blood viscosity, erythropoiesis and iron metabolism

confinement; hypoxia & confinement

physical activity monitoring OTHER

recording of physical activity by actimetry

confinement; hypoxia & confinement

apnea-hypopnea index and nocturnal oxygenation OTHER

recorded by ambulatory sleep recording device

confinement; hypoxia & confinement

24-hour blood pressure OTHER

recorded by ambulatory device

confinement; hypoxia & confinement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Affiliated to a social security scheme
• Ability to communicate and read in English or in French
• Signed written informed consent form after visit with a MD

You may not qualify if:

• Pregnant, lactating or parturient women
• Cardiovascular, pulmonary or neuromuscular disease
• Vulnerable persons

Sponsors & Collaborators

• Ecole Nationale des Sports de Montagne: lead
• Center for Physical Activity Research, University Hospital of Copenhagen, Denmark: collaborator
• Laboratory Mobility, aging & exercise (MOVE) -EA 6314, Faculty of Sport Sciences, University of Poitiers, France: collaborator
• Department for Biomedical Sciences for Health, University of Milan School of Medicine, Milan, Italy: collaborator
• HP2 Laboratory, INSERM, Grenoble Alpes University, CHU Grenoble Alpes, Grenoble, France: collaborator

Study Sites (1)

Ecole nationale des sports de montagne, site de l'Ecole nationale de ski et d'alpinisme

Chamonix, Haute Savoie, 74400, France

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Blood Specimen Collection; Blood Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Vital Signs; Physical Examination; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one group wintering at sea level and one group wintering at high altitude

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 27, 2019
• Study Start: September 27, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)