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Intravascular Volumes in Hypoxia During Antarctic Confinement (ANTARCV)

Primary Purpose

Hypoxia, Confinement

Status
Enrolling by invitation
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
carbon-monoxide rebreathing
venous blood sampling
physical activity monitoring
apnea-hypopnea index and nocturnal oxygenation
24-hour blood pressure
Sponsored by
Ecole Nationale des Sports de Montagne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoxia focused on measuring total red blood cell volume, plasma volume, total hemoglobin mass, total blood volume

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hypoxia & confinement

confinement

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 %).
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).
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.
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.

Secondary Outcome Measures

blood viscosity
Physiological parameter, corresponding to the dynamic viscosity of whole blood, expressed in centipoises, and determined by a cone/plate viscometer
serum erythropoietin
Physiological parameter, corresponding to the serum concentration of erythropoietin expressed in milli-International unit per ml, determined by a specific biological assay.
serum hepcidin
Physiological parameter, corresponding to the serum concentration of hepcidin, expressed in mmol per liter, determined by a specific biological assay.
serum erythroferrone
Physiological parameter, corresponding to the serum concentration of erythroferrone, expressed in ng per ml, determined by a specific biological assay.
serum transferrin saturation
Physiological parameter, corresponding to the serum transferrin saturation, expressed in %, derived from serum iron concentration (in µg/dl) and transferrin concentration (in mg/dl)
serum ferritin
Physiological parameter, corresponding to the serum concentration of ferritin, expressed in ng per ml, determined by a specific biological assay.
serum soluble transferrin receptor
Physiological parameter, corresponding to the serum concentration of soluble transferrin receptor, expressed in nmol per liter, determined by a specific biological assay.
Physical activity
Physiological parameter, corresponding to the level of daily energy expenditure, expressed in kilocalories per kg per day, determined by accelerometry.
Apnea-hypopnea index
Physiological parameter, corresponding to apnea-hypopnea events, expressed in events per hour, recorded by an ambulatory sleep recording device.
Nocturnal oxygenation
Physiological parameter, corresponding to pulse oxygen saturation, expressed in %, recorded by an ambulatory sleep recording device.
24-hour blood pressure
Physiological parameter, corresponding to the mean arterial blood pressure over 24 hours, expressed in mmHg, recorded by an ambulatory device

Full Information

First Posted
September 23, 2019
Last Updated
September 10, 2022
Sponsor
Ecole Nationale des Sports de Montagne
Collaborators
Center for Physical Activity Research, University Hospital of Copenhagen, Denmark, Laboratory Mobility, aging & exercise (MOVE) -EA 6314, Faculty of Sport Sciences, University of Poitiers, France, Department for Biomedical Sciences for Health, University of Milan School of Medicine, Milan, Italy, HP2 Laboratory, INSERM, Grenoble Alpes University, CHU Grenoble Alpes, Grenoble, France
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1. Study Identification

Unique Protocol Identification Number
NCT04106401
Brief Title
Intravascular Volumes in Hypoxia During Antarctic Confinement
Acronym
ANTARCV
Official Title
Alterations in Total Red Blood Cell Volume and Plasma Volume During a One-year Confinement in Antarctica: Effect of Hypoxia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ecole Nationale des Sports de Montagne
Collaborators
Center for Physical Activity Research, University Hospital of Copenhagen, Denmark, Laboratory Mobility, aging & exercise (MOVE) -EA 6314, Faculty of Sport Sciences, University of Poitiers, France, Department for Biomedical Sciences for Health, University of Milan School of Medicine, Milan, Italy, HP2 Laboratory, INSERM, Grenoble Alpes University, CHU Grenoble Alpes, Grenoble, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
INTRODUCTION: Short-term space flight induces an alteration of circulating blood volumes, termed "space flight anemia" and characterized by a decrease in total red blood cell volume (RCV) and plasma volume (PV). This haematological alteration is likely to persist during a long-term space mission and impact the astronauts' health, however this question remains unexplored. During a long-term space mission, the use of hypobaric hypoxia is considered for technical reasons, however the safety of hypoxia must first be verified because this environmental condition causes substantial physiological changes, in particular changes in blood volumes that may interact with the haematological effects of microgravity. OBJECTIVE: using the Antarctic confinement model as a high-fidelity terrestrial analogue for long-duration space missions, the investigators hypothesize that 1) sea level confinement reduces blood volume by simultaneously decreasing RCV and PV, and 2) chronic hypoxia offsets the decrease in RCV and exacerbates the decrease in PV induced by confinement. METHODS: blood volumes will be measured via the carbon-monoxide rebreathing method, repeatedly in two groups of participants, overwintering either at Dumont d'Urville (sea level) or Concordia (altitude 3200 m). The blood viscosity will also be measured, as well as the markers of erythropoiesis and iron metabolism. PERSPECTIVE: Documenting if some degree of hypoxia during long-duration confinement may be beneficial or unfavorable in terms of blood volume regulation is potentially relevant information for the astronauts' health and safety during long-duration space missions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Confinement
Keywords
total red blood cell volume, plasma volume, total hemoglobin mass, total blood volume

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one group wintering at sea level and one group wintering at high altitude
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hypoxia & confinement
Arm Type
Experimental
Arm Description
Participants exposed to high-altitude hypoxia and confinement during a one-year stay at Concordia station, Antarctica (3200 m)
Arm Title
confinement
Arm Type
Active Comparator
Arm Description
Participants exposed to confinement during a one-year stay at Dumont d'Urville station, Antarctica (sea level)
Intervention Type
Other
Intervention Name(s)
carbon-monoxide rebreathing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
venous blood sampling
Intervention Description
venous blood sampling at rest to evaluate blood viscosity, erythropoiesis and iron metabolism
Intervention Type
Other
Intervention Name(s)
physical activity monitoring
Intervention Description
recording of physical activity by actimetry
Intervention Type
Other
Intervention Name(s)
apnea-hypopnea index and nocturnal oxygenation
Intervention Description
recorded by ambulatory sleep recording device
Intervention Type
Other
Intervention Name(s)
24-hour blood pressure
Intervention Description
recorded by ambulatory device
Primary Outcome Measure Information:
Title
total hemoglobin mass
Description
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 %).
Time Frame
15 months
Title
total red blood cell volume
Description
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).
Time Frame
15 months
Title
total blood volume
Description
Physiological parameter, corresponding the the total volume of blood, expressed in liters, and derived from total red blood cell volume and hematocrit.
Time Frame
15 months
Title
plasma volume
Description
Physiological parameter, corresponding to the total volume of plasma, expressed in liters, and derived from total blood volume and total red blood cell volume.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
blood viscosity
Description
Physiological parameter, corresponding to the dynamic viscosity of whole blood, expressed in centipoises, and determined by a cone/plate viscometer
Time Frame
15 months
Title
serum erythropoietin
Description
Physiological parameter, corresponding to the serum concentration of erythropoietin expressed in milli-International unit per ml, determined by a specific biological assay.
Time Frame
15 months
Title
serum hepcidin
Description
Physiological parameter, corresponding to the serum concentration of hepcidin, expressed in mmol per liter, determined by a specific biological assay.
Time Frame
15 months
Title
serum erythroferrone
Description
Physiological parameter, corresponding to the serum concentration of erythroferrone, expressed in ng per ml, determined by a specific biological assay.
Time Frame
15 months
Title
serum transferrin saturation
Description
Physiological parameter, corresponding to the serum transferrin saturation, expressed in %, derived from serum iron concentration (in µg/dl) and transferrin concentration (in mg/dl)
Time Frame
15 months
Title
serum ferritin
Description
Physiological parameter, corresponding to the serum concentration of ferritin, expressed in ng per ml, determined by a specific biological assay.
Time Frame
15 months
Title
serum soluble transferrin receptor
Description
Physiological parameter, corresponding to the serum concentration of soluble transferrin receptor, expressed in nmol per liter, determined by a specific biological assay.
Time Frame
15 months
Title
Physical activity
Description
Physiological parameter, corresponding to the level of daily energy expenditure, expressed in kilocalories per kg per day, determined by accelerometry.
Time Frame
15 months
Title
Apnea-hypopnea index
Description
Physiological parameter, corresponding to apnea-hypopnea events, expressed in events per hour, recorded by an ambulatory sleep recording device.
Time Frame
15 months
Title
Nocturnal oxygenation
Description
Physiological parameter, corresponding to pulse oxygen saturation, expressed in %, recorded by an ambulatory sleep recording device.
Time Frame
15 months
Title
24-hour blood pressure
Description
Physiological parameter, corresponding to the mean arterial blood pressure over 24 hours, expressed in mmHg, recorded by an ambulatory device
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Pregnant, lactating or parturient women Cardiovascular, pulmonary or neuromuscular disease Vulnerable persons
Facility Information:
Facility Name
Ecole nationale des sports de montagne, site de l'Ecole nationale de ski et d'alpinisme
City
Chamonix-Mont-Blanc
State/Province
Haute Savoie
ZIP/Postal Code
74400
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Intravascular Volumes in Hypoxia During Antarctic Confinement

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