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

NCT ID: NCT04132700

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-15
• Study Completion Date: 2020-11-01

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).

Conditions

Metabolism Requirement; Energy Requirement; Indirect Calorimetry

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ICU Patients

Patients admitted to the ICU will be monitored using the Q-NRG for up to 30 mins.

Group Type: EXPERIMENTAL

Q-NRG Metobolic Cart Device

Intervention Type: DEVICE

ICU pateints will be measured using the Q-NRG device for up to 30 mins. These measurements will take place every other day while the patients are in the ICU. Then they will occur a minimum of 3 times a week until discharge.

Interventions

Q-NRG Metobolic Cart Device

ICU pateints will be measured using the Q-NRG device for up to 30 mins. These measurements will take place every other day while the patients are in the ICU. Then they will occur a minimum of 3 times a week until discharge.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Wischmeyer

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00103738

Identifier Type: -

Identifier Source: org_study_id