ObesityUEAIVNNCT02843256
Using Exhaled Air to Determine Changes in Nutritional Status of Patients on Intravenous Nutrition
An observational study of Obesity and Malnourished, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Carbon-12 and carbon-13 are naturally-occurring isotopes that are found in exhaled breath. Investigators have proved that the 13CO2/12CO2 breath delta value (BDV) changes in subjects who were in negative energy balance then fed a positive energy balance meal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Malnourished, Fasting
- What is being tested?
- Isomark Canary
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2016to 10 Jul 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (age 18 or order) with clinical indications for parenteral nutrition who are moderately to severely malnourished due to little to no nutrition by other means (oral nutrition or nutrition per tube) for a period of time (0-10 days based on state of nourishment prior to admission).
Who may be able to join
- 18 years of age or older
- Anticipated start of parenteral nutrition
- Expected duration of stay at least 5 days from enrollment
- Subject speaks English
- Subjects with inability to take adequate oral nutrition who are developing or have developed malnutrition who require parenteral nutrition
Who cannot join
- Subjects unable to coordinate well enough to give a 1 liter breath sample
- Subjects receiving parenteral nutrition prior to admission
- Subjects who are pregnant
- Subjects who are prisoners
- Subjects who are pharmacologically sedated or with altered consciousness
- Subjects who are mechanically ventilated
Show all 9Show fewer
- Subjects admitted for bone marrow or stem cell transplants
- Known participation in another interventional research study within 30 days prior to enrollment (note: to be eligible, any interventional treatment must have ended at least 30 days ago)
- Subjects with disease states or clinical conditions that do not make them study candidates, per the primary investigator's discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Changes in CO2-13/CO2-12 Delta Value in Exhaled Breath to Examine Changes in Metabolism in Patients Being Fed Intravenous Nutrition
Carbon-12 and carbon-13 are naturally-occurring isotopes that are found in exhaled breath. Investigators have proved that the 13CO2/12CO2 breath delta value (BDV) changes in subjects who were in negative energy balance then fed a positive energy balance meal. Measuring one liter of exhaled breath daily may be a more convenient way to measure negative or positive energy balance in patients receiving intravenous nutrition.
Read the detailed description
This is a prospective, pilot study to determine if there is change in the 12C/13C BDV between days 0-7 in patients who receive parenteral nutrition. Investigators will recruit subjects from inpatient units at the University of Wisconsin Hospital and Clinics whose primary team consult the Nutrition Support Team to institute parenteral nutrition for clinical reasons. Subjects with clinical indications for parenteral nutrition are moderately to severely malnourished due to little to no nutrition by other means (oral nutrition or nutrition per tube) for a period of time (0-10 days based on state of nourishment prior to admission).
Investigators will record baseline nutritional status from the medical record notes (dietitian, Nutrition Support Team, etc.), as well as medication, demographic information and medical history. Investigators will take a baseline exhaled CO2 measurement and then a daily measurement at approximately the same time daily (+/- an hour).
The daily exhaled 12C/13C breath delta value will be matched with the subjects' daily caloric intake from parenteral nutrition (and oral nutrition and nutrition per tube, if applicable). The breath delta value, the caloric intake, plus the subjects' degree of malnourishment will be parameters with which to build further research. Investigators hypothesize that the breath delta value will increase from baseline and then stabilize after the patient reaches goal energy needs as defined by the Nutrition Support Team.
- Conditions
- Obesity, Malnourished, Fasting
- Being tested
- Isomark Canary
- Medical subject headings
- Obesity, Malnutrition, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isomark CanaryDevice
The Isomark Canary will analyze the exhaled air and generate a breath delta value.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving intravenous nutrition | Patients will blow into a bag that will capture 500 mL of their exhaled air daily for 7 days or the length of the parenteral nutrition, whichever is shorter. The Isomark Canary will analyze the air to generate a breath delta value. Receives: Device: Isomark Canary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in Breath Delta Value
Investigators will test if the breath delta value (kJ) increases in subjects from baseline (pre-parenteral nutrition) to the subject's goal calculated rate. The time frame tested for each subject will be from baseline to 7 days or the length of parenteral nutrition (whichever is shorter.) Investigators will recruit 20 patients, and this may take 6 months to accomplish. This is a pilot investigation.
Measured: baseline to day 7
Secondary outcomes (3)
Variation in Breath Delta Value from day 0 to day 1 of parenteral nutrition
Investigators hypothesize that the variation in breath delta value (kJ) will show the most dramatic change in subjects receiving parenteral nutrition from baseline to day 1 of parenteral nutrition.
Measured: day 0 to day 1
Subjects and Variation in Breath Delta Value
Investigators hypothesize that the variation in breath delta value (kJ) will show the most variation from baseline to day 7 in subjects who are the most malnourished (that is, the subjects who have lost the most weight prior to starting parenteral nutrition)
Measured: baseline to day 7
Variation in Breath Delta Value when Parenteral Nutrition is interrupted
Investigators hypothesize that there will be a variation in breath delta value (kJ) if parenteral nutrition is interrupted (for clinical purposes, that is, due to a central line infection or other clinical reason.)
Measured: baseline to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study start8 Jun 2016
- Primary completion10 Jul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Isomark, LLC
- Responsible party
- Sponsor
- Investigators
- Kenneth A Kudsk, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843256
- Sponsor's protocol ID
- 2016-0354
- Acronym
- UEAIVN
- Status last verified
- Nov 2017
- First submitted
- 6 Jun 2016
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in CO2-13/CO2-12 Delta Value in Exhaled Breath to Examine Changes in Metabolism in Patients Being Fed Intravenous Nutrition
- ClinicalTrials.gov ID
- NCT02843256
- Acronym / sponsor ID
- UEAIVN / 2016-0354
- Conditions
- Obesity, Malnourished, Fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Isomark, LLC
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 25 Jul 2016 (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.
Carbon-12 and carbon-13 are naturally-occurring isotopes that are found in exhaled breath. Investigators have proved that the 13CO2/12CO2 breath delta value (BDV) changes in subjects who were in negative energy balance then fed a positive energy balance meal. Measuring one liter of exhaled breath daily may be a more convenient way to measure negative or positive energy balance in patients receiving intravenous nutrition.
Detailed description
This is a prospective, pilot study to determine if there is change in the 12C/13C BDV between days 0-7 in patients who receive parenteral nutrition. Investigators will recruit subjects from inpatient units at the University of Wisconsin Hospital and Clinics whose primary team consult the Nutrition Support Team to institute parenteral nutrition for clinical reasons. Subjects with clinical indications for parenteral nutrition are moderately to severely malnourished due to little to no nutrition by other means (oral nutrition or nutrition per tube) for a period of time (0-10 days based on state of nourishment prior to admission).
Investigators will record baseline nutritional status from the medical record notes (dietitian, Nutrition Support Team, etc.), as well as medication, demographic information and medical history. Investigators will take a baseline exhaled CO2 measurement and then a daily measurement at approximately the same time daily (+/- an hour).
The daily exhaled 12C/13C breath delta value will be matched with the subjects' daily caloric intake from parenteral nutrition (and oral nutrition and nutrition per tube, if applicable). The breath delta value, the caloric intake, plus the subjects' degree of malnourishment will be parameters with which to build further research. Investigators hypothesize that the breath delta value will increase from baseline and then stabilize after the patient reaches goal energy needs as defined by the Nutrition Support Team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving intravenous nutrition | – | Device: Isomark CanaryPatients will blow into a bag that will capture 500 mL of their exhaled air daily for 7 days or the length of the parenteral nutrition, whichever is shorter. The Isomark Canary will analyze the air to generate a breath delta value. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (age 18 or order) with clinical indications for parenteral nutrition who are moderately to severely malnourished due to little to no nutrition by other means (oral nutrition or nutrition per tube) for a period of time (0-10 days based on state of nourishment prior to admission).
Key inclusion criteria (5 listed)
- 18 years of age or older
- Anticipated start of parenteral nutrition
- Expected duration of stay at least 5 days from enrollment
- Subject speaks English
- Subjects with inability to take adequate oral nutrition who are developing or have developed malnutrition who require parenteral nutrition
Key exclusion criteria (9 listed)
- Subjects unable to coordinate well enough to give a 1 liter breath sample
- Subjects receiving parenteral nutrition prior to admission
- Subjects who are pregnant
- Subjects who are prisoners
- Subjects who are pharmacologically sedated or with altered consciousness
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 |
|---|---|---|
| Isomark CanaryThe Isomark Canary will analyze the exhaled air and generate a breath delta value. | Device | Patients receiving intravenous nutrition |
Primary outcome
Variation in Breath Delta Value
Time frame: baseline to day 7
Investigators will test if the breath delta value (kJ) increases in subjects from baseline (pre-parenteral nutrition) to the subject's goal calculated rate. The time frame tested for each subject will be from baseline to 7 days or the length of parenteral nutrition (whichever is shorter.) Investigators will recruit 20 patients, and this may take 6 months to accomplish. This is a pilot investigation.
3 secondary outcomes
Variation in Breath Delta Value from day 0 to day 1 of parenteral nutrition
Time frame: day 0 to day 1
Subjects and Variation in Breath Delta Value
Time frame: baseline to day 7
Variation in Breath Delta Value when Parenteral Nutrition is interrupted
Time frame: baseline to day 7
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 28 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Kenneth A Kudsk, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Malnourished, run by University of Wisconsin, Madison 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 5 inclusion and 9 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 28 Nov 2017. 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. 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?
Variation in Breath Delta Value (time frame: baseline to day 7). 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 28 Nov 2017; AzTrials last refreshed its copy on 30 Oct 2026.