NCT04132700

Longitudinal Evaluation of Energy Expenditure in ICU Patients From Admission to Discharge Using A Novel Indirect Calorimeter: LEEP-Forward Trial

Withdrawn NA Last updated 21 May 2021

What this trial tests

NA trial testing Q-NRG Metobolic Cart Device in Metabolism Requirement. Withdrawn.

Timeline

15 March 2020

Primary endpoint
1 November 2020

1 November 2020

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Start date	15 March 2020
Primary completion	1 November 2020
Estimated completion	1 November 2020
Sites	1 location across United States

Drugs / interventions tested

• Q-NRG Metobolic Cart Device

Conditions studied

• Metabolism Requirement — all drugs for Metabolism Requirement →
• Energy Requirement — all drugs for Energy Requirement →
• Indirect Calorimetry — all drugs for Indirect Calorimetry →

Sponsor

Duke University

Who can join

18 and older, any sex, with Metabolism Requirement or Energy Requirement. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.