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Do Changes in Plasma Osmolality Influence Ventilation? (OSM)

Primary Purpose

Hyponatraemia, Hypernatraemia

Status
Completed
Phase
Early Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Water
Saline 3%
Sponsored by
Vibeke Moen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyponatraemia focused on measuring carbon dioxide, ventilation, gender, osmolality, menstruation cycle

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

  • Department of Anaesthesia and Intensive care, Kalmar County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Saline

Water

Arm Description

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

The subjects will drink tap water for 2 hours, the volume calculated as 20ml/kg/hour

Outcomes

Primary Outcome Measures

pCO2
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.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2009
Last Updated
October 15, 2012
Sponsor
Vibeke Moen
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1. Study Identification

Unique Protocol Identification Number
NCT01008644
Brief Title
Do Changes in Plasma Osmolality Influence Ventilation?
Acronym
OSM
Official Title
Do Plasma Osmolality Changes Influence Ventilation, and Are There Gender Differences?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vibeke Moen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatraemia, Hypernatraemia
Keywords
carbon dioxide, ventilation, gender, osmolality, menstruation cycle

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Experimental
Arm Description
The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min.
Arm Title
Water
Arm Type
Experimental
Arm Description
The subjects will drink tap water for 2 hours, the volume calculated as 20ml/kg/hour
Intervention Type
Other
Intervention Name(s)
Water
Other Intervention Name(s)
saline 3%
Intervention Description
The subjects will drink tap water for 2 hours, volume calculated according to weight: 20ml/kg/hour.
Intervention Type
Other
Intervention Name(s)
Saline 3%
Intervention Description
The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min
Primary Outcome Measure Information:
Title
pCO2
Description
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.
Time Frame
ten minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Irestedt. MD PhD
Organizational Affiliation
Department of Anaesthesia and Intensive Care , Karolinska University Hospital, Stockholm
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anaesthesia and Intensive care, Kalmar County Hospital
City
Kalmar
ZIP/Postal Code
39185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
7736341
Citation
Jennings DB. The physicochemistry of [H+] and respiratory control: roles of PCO2, strong ions, and their hormonal regulators. Can J Physiol Pharmacol. 1994 Dec;72(12):1499-512. doi: 10.1139/y94-216.
Results Reference
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PubMed Identifier
16311079
Citation
Weissgerber TL, Wolfe LA, Hopkins WG, Davies GA. Serial respiratory adaptations and an alternate hypothesis of respiratory control in human pregnancy. Respir Physiol Neurobiol. 2006 Aug;153(1):39-53. doi: 10.1016/j.resp.2005.09.004. Epub 2005 Nov 28.
Results Reference
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PubMed Identifier
14614519
Citation
Heenan AP, Wolfe LA. Plasma osmolality and the strong ion difference predict respiratory adaptations in pregnant and nonpregnant women. Can J Physiol Pharmacol. 2003 Sep;81(9):839-47. doi: 10.1139/y03-072.
Results Reference
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Do Changes in Plasma Osmolality Influence Ventilation?

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