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Completed

NCT Number: NCT01008644

Do Changes in Plasma Osmolality Influence Ventilation?

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.

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Key information

Conditions

Hyponatraemia Behavior Coitus Hypernatraemia Hypernatremia Hyponatremia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Sexual Behavior Water-Electrolyte Imbalance

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Anaesthesia and Intensive care, Kalmar County Hospital

Kalmar, Kalmar County, 39185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Water

Other

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

Other names: saline 3%

Saline 3%

Other

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

Primary outcomes

  1. pCO2

    Time frame: ten minutes

    pCO2,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.

Sponsors and collaborators

Lead sponsor

Vibeke Moen

Other

Registry information

Official study title

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

Acronym: OSM

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 6, 2009
Registry last updated
Oct 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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