Clinical trial NCT04132700: Longitudinal Evaluation of Energy Expenditure in ICU Patients From Admission to Discharge Using A Novel Indirect Calorimeter: LEEP-Forward Trial
Official title: Longitudinal Evaluation of Energy Expenditure in ICU Patients From Admission to Discharge Using A Novel Indirect Calorimeter: LEEP-Forward Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Metabolism Requirement
Energy Requirement
Indirect Calorimetry
Keywords: energy expenditure
respiratory quotient
Intensive Care Unit (ICU)
indirect calorimetry
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).


Eligibility criteria: Inclusion Criteria:

* Critically ill patients requiring mechanical ventilation for \> 48 hours
* Patients admitted to Duke Surgical/Trauma ICU, Medical ICU, Cardiothoracic ICU, and Neuro ICU
* Patients must be enrolled within 72 hours of ICU admission

Exclusion Criteria:

* Fraction of inhaled oxygen (FIO2) \> 70%
* Positive end expiratory pressure (PEEP) \> 10cmH2O
* Peak ventilatory pressure \> 30cmH20
* Presence of air leaks from thoracic drain tube
* Changes in vasoactive agent dose (\>20%, \<1 hr before or during IC)
* Agitation or change in sedative/analgesic dose (\>20%, \<1 hr before and/or during IC)
* Change in body temperature (\>0.5°C, \<1 hr before and/or during IC)
* Expected duration of ICU stay \< 24 hours
* Expected survival of the patient \< 24 hours
* Continuous Renal Replacement Therapy (CRRT/CVVH that does not experience an appropriate interruption of at least 60 minutes to allow for indirect calorimetry measurements

Primary outcomes:
measure: Changes of Resting Energy expenditure(REE) over time, as measured by the indirect calorimetry Q-NRG device
timeFrame: 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)
measure: Changes of the Respiratory Exchange Ratio (RER) as measured by the indirect calorimetry Q-NRG device
timeFrame: 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)
Secondary outcomes:
measure: Changes of Intramuscular adipose tissue (IMAT) content from the psoas at the Level of L3/Th3
timeFrame: 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)
measure: Changes of Intramuscular adipose tissue (IMAT) from rectus femurs - vastus laterals - temporalis - styloglossys
timeFrame: 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)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Paul Wischmeyer
role: PRINCIPAL_INVESTIGATOR
References: