Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
26 participants
INTERVENTIONAL
2009-11-30
2010-11-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
FACTORIAL
BASIC_SCIENCE
NONE
Study Groups
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Saline
The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min.
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
Water
The subjects will drink tap water for 2 hours, the volume calculated as 20ml/kg/hour
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* pregnancy,any hormone treatment,
* treatment with diuretics,
* diabetes or kidney disease,
* BMI \> 26,
18 Years
45 Years
ALL
Yes
Sponsors
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Vibeke Moen
OTHER
Responsible Party
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Vibeke Moen
MD, Department of Anaesthesia
Principal Investigators
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Lars Irestedt. MD PhD
Role: STUDY_DIRECTOR
Department of Anaesthesia and Intensive Care , Karolinska University Hospital, Stockholm
Locations
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Department of Anaesthesia and Intensive care, Kalmar County Hospital
Kalmar, Kalmar County, Sweden
Countries
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References
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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.
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.
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.
Other Identifiers
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M-126-09
Identifier Type: -
Identifier Source: org_study_id