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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

Tracking Information
First Submitted Date June 6, 2016
First Posted Date July 25, 2016
Last Update Posted Date November 28, 2017
Actual Study Start Date June 8, 2016
Actual Primary Completion Date July 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2016)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02843256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 20, 2016)
  • 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.
  • 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)
  • 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.)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Using Exhaled Air to Determine Changes in Nutritional Status of Patients on Intravenous Nutrition
Official Title Changes in CO2-13/CO2-12 Delta Value in Exhaled Breath to Examine Changes in Metabolism in Patients Being Fed Intravenous Nutrition
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Obesity
  • Malnourished
  • Fasting
Intervention Device: Isomark Canary
The Isomark Canary will analyze the exhaled air and generate a breath delta value.
Study Groups/Cohorts 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.
Intervention: Device: Isomark Canary
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 20, 2016)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date July 10, 2017
Actual Primary Completion Date July 10, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02843256
Other Study ID Numbers 2016-0354
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Wisconsin, Madison
Study Sponsor University of Wisconsin, Madison
Collaborators Isomark, LLC
Investigators
Principal Investigator: Kenneth A Kudsk, MD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date November 2017