HyponatraemiaEarly Phase 1OSMNCT01008644
Do Changes in Plasma Osmolality Influence Ventilation?
A Early Phase 1 study testing Water and Saline 3% in people with Hyponatraemia and Hypernatraemia, run by Vibeke Moen at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyponatraemia, Hypernatraemia
- What is being tested?
- Water and Saline 3%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2009to Nov 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females with regular menstruations, males
Who cannot join
- Consumption of nicotine, BMI > 26,
- pregnancy,any hormone treatment,
- treatment with diuretics,
- diabetes or kidney disease,
- BMI > 26,
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Anaesthesia and Intensive care, Kalmar County Hospital
Kalmar, Kalmar County, 39185
About this study
Official title: Do Plasma Osmolality Changes Influence Ventilation, and Are There Gender Differences?
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.
Read the 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.
- Conditions
- Hyponatraemia, Hypernatraemia
- Being tested
- Water, Saline 3%
- Keywords
- carbon dioxide, ventilation, gender, osmolality, menstruation cycle
- Medical subject headings
- Hyponatremia, Hypernatremia, Respiratory Aspiration, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
Also called saline 3%
The subjects will drink tap water for 2 hours, volume calculated according to weight: 20ml/kg/hour.
Saline 3%Other
The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Saline | Experimental | The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min. Receives: Other: Water; Other: Saline 3% |
| Water | Experimental | The subjects will drink tap water for 2 hours, the volume calculated as 20ml/kg/hour Receives: Other: Water; Other: Saline 3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HyponatraemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibeke Moen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vibeke Moen, Kalmar County Hospital
- Investigators
- Lars Irestedt. MD PhD, Study director, Department of Anaesthesia and Intensive Care , Karolinska University Hospital, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008644
- Sponsor's protocol ID
- M-126-09
- Acronym
- OSM
- Status last verified
- Oct 2012
- First submitted
- 5 Nov 2009
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 7736341Weissgerber 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.
PubMed 16311079Heenan 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.
PubMed 14614519
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Plasma Osmolality Changes Influence Ventilation, and Are There Gender Differences?
- ClinicalTrials.gov ID
- NCT01008644
- Acronym / sponsor ID
- OSM / M-126-09
- Conditions
- Hyponatraemia, Hypernatraemia
- Keywords
- carbon dioxide, ventilation, gender, osmolality, menstruation cycle
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Vibeke MoenUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Experimental | Other: Water, Other: Saline 3%The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min. |
| Water | Experimental | Other: Water, Other: Saline 3%The subjects will drink tap water for 2 hours, the volume calculated as 20ml/kg/hour |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Females with regular menstruations, males
Key exclusion criteria (5 listed)
- Consumption of nicotine, BMI > 26,
- pregnancy,any hormone treatment,
- treatment with diuretics,
- diabetes or kidney disease,
- BMI > 26,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaterAlso: saline 3%The subjects will drink tap water for 2 hours, volume calculated according to weight: 20ml/kg/hour. | Other | Saline, Water |
| Saline 3%The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min | Other | Saline, Water |
Primary outcome
pCO2
Time frame: ten minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
- Background: PubMed 7736341Jennings 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.
- Background: PubMed 16311079Weissgerber 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.
- Background: PubMed 14614519Heenan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Irestedt. MD PhD study director
Department of Anaesthesia and Intensive Care , Karolinska University Hospital, Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Water and Saline 3% in people with Hyponatraemia and Hypernatraemia, run by Vibeke Moen at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCO2 (time frame: ten minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01008644, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2012.