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

Obesity Clinical Trial

— UEAIVN  

Official title:

Changes in CO2-13/CO2-12 Delta Value in Exhaled Breath to Examine Changes in Metabolism in Patients Being Fed Intravenous Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02843256
• Other study ID #: 2016-0354
• Status: Completed
• Phase: N/A
• First received: June 6, 2016
• Last updated: November 26, 2017
• Start date: June 8, 2016
• Est. completion date: July 10, 2017

Study information

• Verified date: November 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fasting
• Malnourished
• Malnutrition
• Obesity

Intervention

Device:
• Isomark Canary
The Isomark Canary will analyze the exhaled air and generate a breath delta value.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Isomark, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline to day 7
Secondary	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.	day 0 to day 1
Secondary	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)	baseline to day 7
Secondary	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.)	baseline to day 7