Water StressNCT04233606
Influence of Osmotic Stimulation of Vasopressin on Autonomic Function
A study testing Hypertonic Saline and Normal Saline in people with Water Stress and Body Water Dehydration, run by University of North Carolina, Greensboro at 1 site in United States.
Trial summary
The regulation of total body water that defines human hydration status is a complex and dynamic process. Current methods of assessing hydration status (e.g. hematologic and urinary analyses) lack the ability to track changes in hydration status in real-time due to whole-body homeostatic physiologic processes required… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Water Stress, Body Water Dehydration
- What is being tested?
- Hypertonic Saline and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2023to Jul 2024
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and Females between the ages of 18 - 35
Who cannot join
- 1) evidence of clinically relevant diseases that may alter body water regulation (e.g., diabetes, kidney disease, metabolic disorders, cardiovascular disease, and other potential fluid balance covariates such as habitual use of non-steroidal anti-inflammatory drugs or serotonin reuptake inhibitors,
- 2) previous surgery on the digestive tract that may impair the body's ability to normally regulate body water,
- 3) regular drug treatment within the previous 15 days,
- 4) actively attempting to gain or lose body weight,
- 5) For female participants, testing will take place during the early follicular phase of their menstrual cycle (days 1-8) to maintain consistency in the hydration status measures as total body water fluctuates over the course of the menstrual cycle. Females who are currently using contraceptives (e.g., IUD) that limit the number of menstrual cycles occurring in a given year will be excluded from this study to ensure accuracy in the testing periods for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Greensboro
Greensboro, North Carolina, 27412
About this study
The regulation of total body water that defines human hydration status is a complex and dynamic process. Current methods of assessing hydration status (e.g. hematologic and urinary analyses) lack the ability to track changes in hydration status in real-time due to whole-body homeostatic physiologic processes required to maintain central pressure and cardiovascular function. This project will address this problem by assessing the relationship between autonomic function (measured using heart rate variability), a brain-derived process that regulates cardiovascular function, and changes in the hydration-mediated hormone vasopressin.
- Conditions
- Water Stress, Body Water Dehydration
- Being tested
- Hypertonic Saline, Normal Saline
- Keywords
- Vasopressin, Heart Rate Variability, Cardiovascular Function, Autonomic Function
- Medical subject headings
- Dehydration, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic SalineOther
Infusion of hypertonic saline to induce an osmotic secretion of the hormone vasopressin
Normal SalineOther
Infusion of normal saline to inhibit the secretion of the hormone vasopressin
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants will be infused with normal (0.9% NaCL) saline for a 120 minute period. Receives: Other: Normal Saline |
| Hypertonic Saline | Experimental | Participants will be infused with hypertonic (3% NaCL) saline for a 120 minute period. Receives: Other: Hypertonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in autonomic function
Changes in parasympathetic and sympathetic tone as measured by heart rate variability
Measured: 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes of saline infusion period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study startNov 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Why it stopped: PI left the university and is no longer in a full time employment role
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Water StressStudies 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete two trials under two different hydration states: isovolemic increase in plasma osmolality and isovolemic control (maintain normal plasma osmolality)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Adams, University of North Carolina, Greensboro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233606
- Sponsor's protocol ID
- 20-0206
- Status last verified
- Nov 2023
- First submitted
- 15 Jan 2020
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Osmotic Stimulation of Vasopressin on Autonomic Function
- ClinicalTrials.gov ID
- NCT04233606
- Acronym / sponsor ID
- 20-0206
- Conditions
- Water Stress, Body Water Dehydration
- Keywords
- Vasopressin, Heart Rate Variability, Cardiovascular Function, Autonomic Function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the university and is no longer in a full time employment role
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 18 Jan 2020 (actual)
- 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.
The regulation of total body water that defines human hydration status is a complex and dynamic process. Current methods of assessing hydration status (e.g. hematologic and urinary analyses) lack the ability to track changes in hydration status in real-time due to whole-body homeostatic physiologic processes required to maintain central pressure and cardiovascular function. This project will address this problem by assessing the relationship between autonomic function (measured using heart rate variability), a brain-derived process that regulates cardiovascular function, and changes in the hydration-mediated hormone vasopressin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete two trials under two different hydration states: isovolemic increase in plasma osmolality and isovolemic control (maintain normal plasma osmolality)
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Normal SalineParticipants will be infused with normal (0.9% NaCL) saline for a 120 minute period. |
| Hypertonic Saline | Experimental | Other: Hypertonic SalineParticipants will be infused with hypertonic (3% NaCL) saline for a 120 minute period. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males and Females between the ages of 18 - 35
Key exclusion criteria (5 listed)
- 1) evidence of clinically relevant diseases that may alter body water regulation (e.g., diabetes, kidney disease, metabolic disorders, cardiovascular disease, and other potential fluid balance covariates such as habitual use of non-steroidal anti-inflammatory drugs or serotonin reuptake inhibitors,
- 2) previous surgery on the digestive tract that may impair the body's ability to normally regulate body water,
- 3) regular drug treatment within the previous 15 days,
- 4) actively attempting to gain or lose body weight,
- 5) For female participants, testing will take place during the early follicular phase of their menstrual cycle (days 1-8) to maintain consistency in the hydration status measures as total body water fluctuates over the course of the menstrual cycle. Females who are currently using contraceptives (e.g., IUD) that limit the number of menstrual cycles occurring in a given year will be excluded from this study to ensure accuracy in the testing periods for this study.
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 |
|---|---|---|
| Hypertonic SalineInfusion of hypertonic saline to induce an osmotic secretion of the hormone vasopressin | Other | Hypertonic Saline |
| Normal SalineInfusion of normal saline to inhibit the secretion of the hormone vasopressin | Other | Control |
Primary outcome
Change in autonomic function
Time frame: 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes of saline infusion period
Changes in parasympathetic and sympathetic tone as measured by heart rate variability
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertonic Saline and Normal Saline in people with Water Stress and Body Water Dehydration, run by University of North Carolina, Greensboro at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 13 Nov 2023. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in autonomic function (time frame: 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes of saline infusion period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2023.