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Do Changes in Plasma Osmolality Influence Ventilation? (OSM)

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ClinicalTrials.gov Identifier: NCT01008644
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : October 17, 2012
Sponsor:
Information provided by (Responsible Party):
Vibeke Moen, Kalmar County Hospital

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.


Condition or disease Intervention/treatment Phase
Hyponatraemia Hypernatraemia Other: Water Other: Saline 3% Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Do Plasma Osmolality Changes Influence Ventilation, and Are There Gender Differences?
Study Start Date : November 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Saline
The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min.
Other: Water
The subjects will drink tap water for 2 hours, volume calculated according to weight: 20ml/kg/hour.
Other Name: saline 3%

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

Experimental: Water
The subjects will drink tap water for 2 hours, the volume calculated as 20ml/kg/hour
Other: Water
The subjects will drink tap water for 2 hours, volume calculated according to weight: 20ml/kg/hour.
Other Name: saline 3%

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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008644


Locations
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Sweden
Department of Anaesthesia and Intensive care, Kalmar County Hospital
Kalmar, Sweden, 39185
Sponsors and Collaborators
Vibeke Moen
Investigators
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Study Director: Lars Irestedt. MD PhD Department of Anaesthesia and Intensive Care , Karolinska University Hospital, Stockholm

Publications:
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Responsible Party: Vibeke Moen, MD, Department of Anaesthesia, Kalmar County Hospital
ClinicalTrials.gov Identifier: NCT01008644    
Other Study ID Numbers: M-126-09
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: October 17, 2012
Last Verified: October 2012
Keywords provided by Vibeke Moen, Kalmar County Hospital:
carbon dioxide
ventilation
gender
osmolality
menstruation cycle
Additional relevant MeSH terms:
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Hyponatremia
Hypernatremia
Water-Electrolyte Imbalance
Metabolic Diseases