Ignite Creation Date:
2024-05-05 @ 9:59 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01008644
Status:
COMPLETED
Last Update Posted:
2012-10-17
First Post:
2009-11-05
Brief Title:
Do Changes in Plasma Osmolality Influence Ventilation
Sponsor:
Vibeke Moen
Organization:
Kalmar County Hospital
Study Overview
Official Title:
Do Plasma Osmolality Changes Influence Ventilation and Are There Gender Differences
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSM
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 subjects sensitivity to carbon dioxide will be tested and blood samples will be drawn for analysis of blood gaseselectrolyte and osmolalitySubjects 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
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 subjects sensitivity to carbon dioxide will be tested and blood samples will be drawn for analysis of blood gaseselectrolyte and osmolalitySubjects 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 salineBefore 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 recordedBlood 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None