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
|Condition or disease||Intervention/treatment|
|Obesity Malnourished Fasting||Device: Isomark Canary|
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|
|Actual Enrollment :||20 participants|
|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|
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.
- 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.
- 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.)
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
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Kenneth A Kudsk, MD||University of Wisconsin, Madison|