Longitudinal Energy Expenditure and Metabolic Effects in Patients With COVID-19 (LEEP-COVID)

NCT04350073 | Completed FDA Device

• 1 other identifier: Pro00105221
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This current proposal evaluates the Longitudinal Energy Expenditure and Metabolic Effects in Patients with COVID-19 (LEEP-COVID) to understand, guide and optimize our metabolic and nutritional care of these high risk patients. As no data exist for the metabolic effects of COVID-19 patients, this data is urgently needed and essential to assist in the care of COVID-19 patients worldwide. We are uniquely positioned at Duke to perform this research, as we are the only US center with 2 of the FDA-approved devices in existence currently capable of collecting this vital data to guide the care of COVID-19 patients worldwide.

Conditions

COVID-19

Keywords

Respiratory failure; metabolic phenotype; mitochondrial phenotype; cardiometabolic phenotype; sarcopenia; malnutrition; critical care; muscle mass; cardiac function; heart failure; energy expenditure; nutrition; intensive care; COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• Metabolic and Nutritional Needs of COVID-19 Patients: Measured by Changes of Resting Energy expenditure(REE) over time, as measured by the indirect calorimetry Q-NRG device

  The amount of CO2 produced combined with O2 consumed is called the REE (kcal/day) and is measured by the gases exchanged at the mouth.

  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)

• Metabolic and Nutritional Needs of COVID-19 Patients:Changes of the Respiratory Exchange Ratio (RER) as measured by the indirect calorimetry Q-NRG device

  RER (ratio of CO2 produced to O2 consumed is called the respiratory exchange ratio (RER) and is measured by the gases exchanged at the mouth

  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)

• Cardiac Output and Cardiac Measures (non-invasive) in COVID-19 patients

  Non-invasive, accurate calculation of cardiac output and other cardiac function measurements via Fick equation using direct measurement of VO2 \& VCO2. As COVID-19 is known to have significant risk of cardiac failure \& cardiac death this may allow early detection of cardiac changes that otherwise may not be recognized in these patients who will not routinely have invasive cardiac monitoring (I.e. Swan-Ganz catheter)

  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 (4)

• Muscle Mass and Quality Changes from COVID-19: Measured via Changes of Intramuscular Adipose Tissue (IMAT) Content From CT Scans of the Psoas at the Level of L3/Th3

  Up to 1 year

• Muscle Mass, Quality, Glycogen Changes in COVID-19: Via Metabolic/Muscle Imaging Derived From Muscle-Specific Ultrasound of Leg/Intercostal/Head Muscles

  Every 3 days (+/- 1 day) while in ICU and then every 5 days (+/- 2 days) for the remainder of hospital stay. Maximum frequency, if requested by the clinical team (for the purposes of clinical care) can be up to once a day, every day.)

• Body Composition in COVID-19 Patients: Measured via Multifrequency Bioimpedance Spectroscopy

  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)

• Phase Angle in COVID-19 Patients: Measured via Multifrequency

  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)

Study Arms (2)

COVID-19 ICU Patients

COVID-10 patients with respiratory failure admitted to the ICU

Device: Q-NRG Metobolic Cart Device; Device: MuscleSound Ultrasound; Device: Multifrequency Bioimpedance Spectroscopy

ICU Patients (Control)

Non-COVID-19 respiratory failure patients requiring mechanical ventilation \> 48 h receiving similar ICU standards of care at Duke

Device: Q-NRG Metobolic Cart Device; Device: MuscleSound Ultrasound; Device: Multifrequency Bioimpedance Spectroscopy

Interventions

Q-NRG Metobolic Cart Device DEVICE

COVID-19 ICU patients 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.

COVID-19 ICU Patients; ICU Patients (Control)

MuscleSound Ultrasound DEVICE

COVID-19 ICU patients will have muscle mass, muscle glycogen, and muscle quality measured at rectus femoris (leg), intercostal, and temporal muscle. 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.

Also known as: Muscle Mass Ultrasound

COVID-19 ICU Patients; ICU Patients (Control)

Multifrequency Bioimpedance Spectroscopy DEVICE

COVID-19 ICU patients will have body composition and phase angle measured using Multifrequency Bioimpedance Spectroscopy. 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.

Also known as: InBody S10 BIA

COVID-19 ICU Patients; ICU Patients (Control)

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

Critically ill COVID-19 or non-COVID-19 patients greater or equal to 18 years of age patients requiring mechanical ventilation for \> 48 hours who are admitted to Duke Surgical/Trauma ICU, Medical ICU, Cardiothoracic ICU, and Neuro ICU from admission to hospital discharge

You may qualify if:

• Critically ill COVID-19 patients greater or equal to 18 years of age patients requiring mechanical ventilation for \> 48 hours who are admitted to Duke Surgical/Trauma ICU, Medical ICU, Cardiothoracic ICU, and Neuro ICU from admission to hospital discharge
• Patients must be enrolled within 72 hours of ICU admission
• Control: non-COVID-19 respiratory failure patients requiring mechanical ventilation \> 48 h receiving similar ICU standards of care at Duke

You may not qualify if:

• Age less than 18 years old
• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medial Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency; Sarcopenia; Malnutrition; Heart Failure

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Paul E Wischmeyer, MD, EDIC, FASPEN, FCCM

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: April 20, 2020
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)