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

NCT02843256 | Completed

• 1 other identifier: 2016-0354
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Malnourished; Fasting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Variation in Breath Delta Value from day 0 to day 1 of parenteral nutrition

  day 0 to day 1

• Subjects and Variation in Breath Delta Value

  baseline to day 7

• Variation in Breath Delta Value when Parenteral Nutrition is interrupted

  baseline to day 7

Study Arms (1)

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

Interventions

Isomark Canary DEVICE

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

Patients receiving intravenous nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Isomark, LLC: collaborator

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Obesity; Malnutrition; Fasting

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Kenneth A Kudsk, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: July 25, 2016
• Study Start: June 8, 2016
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

US (1)