An Early Phase 1 interventional study of Water and Saline 3% in Hyponatraemia and Hypernatraemia, sponsored by Vibeke Moen. Completed at 1 site in Sweden. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-17.
Sponsored by Vibeke Moen · Early Phase 1, Interventional, and Basic science
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.
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.
164 studies on the registry are indexed under Hyponatremia; 16 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 98 interventional studies indexed under Hyponatremia.
Browse Hyponatremia studies →This is the only study on the registry with Vibeke Moen as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min.
Other: Water · Other: Saline 3%
The subjects will drink tap water for 2 hours, the volume calculated as 20ml/kg/hour
Other: Water · Other: Saline 3%
The subjects will drink tap water for 2 hours, volume calculated according to weight: 20ml/kg/hour.
Also known as: saline 3%
The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min
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.
Time frame: ten minutes
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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