Do Changes in Plasma Osmolality Influence Ventilation?

Hypernatraemia Clinical Trial

— OSM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008644
• Other study ID #: M-126-09
• Status: Completed
• Phase: Phase 0
• First received: November 5, 2009
• Last updated: October 15, 2012
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: October 2012
• Source: Kalmar County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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,

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypernatraemia
• Hypernatremia
• Hyponatraemia
• Hyponatremia

Intervention

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

Locations

Country	Name	City	State
Sweden	Department of Anaesthesia and Intensive care, Kalmar County Hospital	Kalmar

Sponsors (1)

Lead Sponsor	Collaborator
Vibeke Moen

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View 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. Review. — View 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. Epub 2005 Nov 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	ten minutes	No