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ICU Patients for Indirect Calorimetry

N/A
Waitlist Available
Led By Paul Wischmeyer
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum of every other day while in icu (up to 10 days). once discharged from icu minimum of 3x a week until discharge (up to 3 weeks)
Awards & highlights

Summary

The purpose of this study is to utilize the new indirect calorimetry Q-NRG device to the measurement of energy expenditure (EE) throughout your intensive care unit (ICU) stay and ultimately address fundamental questions about metabolism and energy requirements for critically ill patients. The study will use a new, investigational calorimeter called the Q-NRG (the study device, supplied by Cosmed, Italy). The word "investigational" means the study drug or device or biologic is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). A calorimeter is a device that connects to your breathing machine tubing for a short period (about 30 minutes) and helps to determine what nutrition you may need in your current condition. There are FDA approved calorimeters that have been used as the current standard of care. These devices and the new Q-NRG calorimeter measure oxygen consumption and carbon dioxide production (the gas you breathe out when you exhale) and calculate energy expenditure. Unfortunately, previously existing calorimeters are complicated to use, cumbersome and require time for measurements. It is hoped the new calorimeter will be easier and more practical to use and, through the measurements we take, we will have a better understanding of a patient's caloric needs for healing. Muscle mass and quality play a role in determining EE and metabolic needs. Massive loss of muscle mass and quality that occurs in critical illness significantly affects EE and nutritional needs and should be accounted for in clinical nutrition delivery. Imaging (standard of care abdominal CT and MSK ultrasound) will be used to assess muscle mass, and muscle quality (amount of intramuscular adipose content; IMAT).

Eligible Conditions
  • Metabolic Requirement
  • Energy Requirement
  • Indirect Calorimetry

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum of every other day while in icu (up to 10 days). once discharged from icu minimum of 3x a week until discharge (up to 3 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum of every other day while in icu (up to 10 days). once discharged from icu minimum of 3x a week until discharge (up to 3 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes of Resting Energy expenditure(REE) over time, as measured by the indirect calorimetry Q-NRG device
Changes of the Respiratory Exchange Ratio (RER) as measured by the indirect calorimetry Q-NRG device
Secondary outcome measures
Changes of Intramuscular adipose tissue (IMAT) content from the psoas at the Level of L3/Th3
Changes of Intramuscular adipose tissue (IMAT) from rectus femurs - vastus laterals - temporalis - styloglossys

Trial Design

1Treatment groups
Experimental Treatment
Group I: ICU PatientsExperimental Treatment1 Intervention
Patients admitted to the ICU will be monitored using the Q-NRG for up to 30 mins.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Q-NRG Metobolic Cart Device
2020
N/A
~70

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Who is running the clinical trial?

Duke UniversityLead Sponsor
2,394 Previous Clinical Trials
3,059,486 Total Patients Enrolled
Paul WischmeyerPrincipal InvestigatorDuke University
2 Previous Clinical Trials
500 Total Patients Enrolled
~0 spots leftby Sep 2025