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Using Exhaled Air to Determine Changes in Nutritional Status of Patients on Intravenous Nutrition (UEAIVN)

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ClinicalTrials.gov Identifier: NCT02843256
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : November 28, 2017
Sponsor:
Collaborator:
Isomark, LLC
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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. 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.

Condition or disease Intervention/treatment
Obesity Malnourished Fasting Device: Isomark Canary

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.


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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in CO2-13/CO2-12 Delta Value in Exhaled Breath to Examine Changes in Metabolism in Patients Being Fed Intravenous Nutrition
Actual Study Start Date : June 8, 2016
Actual Primary Completion Date : July 10, 2017
Actual Study Completion Date : July 10, 2017

Group/Cohort Intervention/treatment
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.
Device: Isomark Canary
The Isomark Canary will analyze the exhaled air and generate a breath delta value.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Variation in Breath Delta Value from day 0 to day 1 of parenteral nutrition [ Time Frame: day 0 to day 1 ]
    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.

  2. Subjects and Variation in Breath Delta Value [ Time Frame: baseline to day 7 ]
    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)

  3. Variation in Breath Delta Value when Parenteral Nutrition is interrupted [ Time Frame: baseline to day 7 ]
    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.)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843256


Locations
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United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Isomark, LLC
Investigators
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Principal Investigator: Kenneth A Kudsk, MD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02843256     History of Changes
Other Study ID Numbers: 2016-0354
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders