Development of Non-invasive ProtocolNCT03447574
Fluid Volume During Fluid Shifts
A study testing ethanol dilution in people with Development of Non-invasive Protocol, run by Mayo Clinic at 3 sites in United States.
Trial summary
This study is designed to answer the question of if several non-invasive methods are comparable to the invasive clinical gold standard of radiolabeled albumin in terms of detecting changes in fluid volume. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Development of Non-invasive Protocol
- What is being tested?
- ethanol dilution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jun 2018to 26 Oct 2022
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Non-smokers
- Have a BMI<30
- Have no chronic disease
- Be free of medications with known cardiovascular effects
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Non-invasive Fluid Volume During Fluid Shifts Technique Validation
This study is designed to answer the question of if several non-invasive methods are comparable to the invasive clinical gold standard of radiolabeled albumin in terms of detecting changes in fluid volume.
It is broken into two studies: Aim 1 Study A is designed as a pilot phase to develop the non-techniques, and Aim 2 Study B is comparing these techniques to the gold standard.
- Conditions
- Development of Non-invasive Protocol
- Being tested
- ethanol dilution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethanol dilutionOther
Ethanol has been validated against deuterium oxide, the invasive gold standard for determining totally body water
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 | Experimental | The ethanol dilution is, in essence, a non-invasive dilution method. It is of interest because of how ethanol readily dissolves itself exclusively into the water space of the body[4], is non-toxic in reasonable concentrations, is metabolized in a 0th order reaction above concentrations of 0.015 g/dL[4], and there are non-invasive methods for determining blood alcohol concentration[5, 6]. Thus, by drinking a known amount of ethanol, total body water can be calculated after a few hours of periodic breathalyzer analyses. Ethanol has been validated against deuterium oxide, the invasive gold standard for determining total body water[4]. The ethanol dose will be 0.5g/kg body weight. Receives: Other: ethanol dilution |
| Aim 2 | Active comparator | 30mL/kg body weight of saline will be rapidly infused after the baseline measurements completed in Aim 1. Non-invasive methods for fluid volume determination (CO-pulse-oximetry, ethanol breathalyzer, BIS) will be conducted and change from baseline calculated. To determine if non-invasive fluid volume techniques can accurately determine fluid changes in healthy participants.Non-invasive methods for fluid volume determination (CO-pulse-oximetry, ethanol breathalyzer, BIS) will be conducted and change from baseline calculated. Receives: Other: ethanol dilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation against Gold Standard
The non-invasive methods being investigated will be non-inferior in measuring the blood or fluid volumes in healthy participants when compared to the gold standard.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start27 Jun 2018
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development of Non-invasive ProtocolStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Johnson, Mayo Clinic
- Investigators
- Bruce D Johnson, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447574
- Sponsor's protocol ID
- 17-007104
- Status last verified
- Dec 2022
- First submitted
- 16 Feb 2018
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Fluid Volume During Fluid Shifts Technique Validation
- ClinicalTrials.gov ID
- NCT03447574
- Acronym / sponsor ID
- 17-007104
- Conditions
- Development of Non-invasive Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 27 Feb 2018 (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.
This study is designed to answer the question of if several non-invasive methods are comparable to the invasive clinical gold standard of radiolabeled albumin in terms of detecting changes in fluid volume.
It is broken into two studies: Aim 1 Study A is designed as a pilot phase to develop the non-techniques, and Aim 2 Study B is comparing these techniques to the gold standard.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1 | Experimental | Other: ethanol dilutionThe ethanol dilution is, in essence, a non-invasive dilution method. It is of interest because of how ethanol readily dissolves itself exclusively into the water space of the body[4], is non-toxic in reasonable concentrations, is metabolized in a 0th order reaction above concentrations of 0.015 g/dL[4], and there are non-invasive methods for determining blood alcohol concentration[5, 6]. Thus, by drinking a known amount of ethanol, total body water can be calculated after a few hours of periodic breathalyzer analyses. Ethanol has been validated against deuterium oxide, the invasive gold standard for determining total body water[4]. The ethanol dose will be 0.5g/kg body weight. |
| Aim 2 | Active comparator | Other: ethanol dilution30mL/kg body weight of saline will be rapidly infused after the baseline measurements completed in Aim 1. Non-invasive methods for fluid volume determination (CO-pulse-oximetry, ethanol breathalyzer, BIS) will be conducted and change from baseline calculated. To determine if non-invasive fluid volume techniques can accurately determine fluid changes in healthy participants.Non-invasive methods for fluid volume determination (CO-pulse-oximetry, ethanol breathalyzer, BIS) will be conducted and change from baseline calculated. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ethanol dilutionEthanol has been validated against deuterium oxide, the invasive gold standard for determining totally body water | Other | Aim 1, Aim 2 |
Primary outcome
Validation against Gold Standard
Time frame: 2 years
The non-invasive methods being investigated will be non-inferior in measuring the blood or fluid volumes in healthy participants when compared to the gold standard.
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 8 Dec 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Bruce D Johnson principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ethanol dilution in people with Development of Non-invasive Protocol, run by Mayo Clinic at 3 sites 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?
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 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 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?
Validation against Gold Standard (time frame: 2 years). 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 8 Dec 2022.