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Do Changes in Plasma Osmolality Influence Ventilation?

Do Plasma Osmolality Changes Influence Ventilation, and Are There Gender Differences?

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01008644
Acronym
OSM
Enrollment
26
Registered
2009-11-06
Start date
2009-11-30
Completion date
2010-11-30
Last updated
2012-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypernatraemia, Hyponatraemia

Keywords

carbon dioxide, ventilation, gender, osmolality, menstruation cycle

Brief summary

Primary hypothesis: osmolality changes influence the sensitivity of the respiratory center to carbon dioxide, hyponatraemia causing hyperventilation, and hypernatraemia depressing ventilation. Secondary hypothesis: There are gender differences in the sensitivity to osmolality changes. 10 women and 10 men will on different occasions drink water or receive hypertonic saline intravenously, in order to lower or increase plasma osmolality. The women will participate during both faces of the menstruation cycle. On each occasion the subject´s sensitivity to carbon dioxide will be tested, and blood samples will be drawn for analysis of blood gases,electrolyte and osmolality.Subjects who interrupt participation before completion of all planned occasions, will be substituted, so that 10 subjects of either sex will have participated as planned. All results from all participants will be analyzed.

Detailed description

Healthy volunteers will on different occasions be subject to reduced plasma osmolality caused by drinking water, and increased osmolality caused by intravenous infusion of hypertonic saline.Before and after each osmolality change, sensitivity to carbon dioxide will be tested by partial rebreathing through a so called Bain-system. Throughout the whole experiment heart rate, blood pressure and oxygen saturation will be recorded.Blood samples will be collected before each rebreathing test and every 20 minutes during the two hours of water or salt load. Urine will be collected and analysed.

Interventions

OTHERWater

The subjects will drink tap water for 2 hours, volume calculated according to weight: 20ml/kg/hour.

OTHERSaline 3%

The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min

Sponsors

Vibeke Moen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Females with regular menstruations, males

Exclusion criteria

* Consumption of nicotine, BMI \> 26, * pregnancy,any hormone treatment, * treatment with diuretics, * diabetes or kidney disease, * BMI \> 26,

Design outcomes

Primary

MeasureTime frameDescription
pCO2ten minutespCO2,osmolality and sensitivity to CO2 will be recorded 10 minutes before before and 10 minutes after administering water or saline for two hours.The results will be analyzed for differences before and after osmolality changes in every single individual, and differences between females in luteal or follicular menstruation phase.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026