Using Exhaled Air to Determine Changes in Nutritional Status of Patients on Intravenous Nutrition
Status: | Completed |
---|---|
Conditions: | Food Studies, Obesity Weight Loss |
Therapuetic Areas: | Endocrinology, Pharmacology / Toxicology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/30/2017 |
Start Date: | June 8, 2016 |
End Date: | July 10, 2017 |
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.
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.
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.
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.
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
We found this trial at
1
site
600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
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