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

Detailed Description

Currently, no longitudinal data exist describing the metabolic and cardiac effects of SARS-CoV-2 (COVID-19) infection. This data is urgently needed to assist in care and promote recovery of COVID-19 patients worldwide, and elderly patients who are at higher risk due to increased age, pre-existing risk factors (frailty, sarcopenia, malnutrition), and co-morbid conditions. Further, new pathologies such as COVID-19-related cardiac dysfunction must be described and rapidly identified. Our innovative measurements will provide direct non-invasive assessments of the effect of COVID-19 infection on key measures including energy expenditure, substrate utilization, muscle mass, cardiac function, mitochondrial function, and body composition. In addition, we will be able to provide objective data on key recovery intervention requirements including energy/nutritional requirements, effects of nutrition and rehabilitation efforts on muscle mass and energy state, and recovery of cardiac, muscle function.

Study Questions: We propose to evaluate longitudinal metabolic and cardiac pathophysiology in patients with COVID-19 to understand, guide and optimize our metabolic clinical care during acute hospitalization. Further, this data will be essential in providing objective data to guide physical recovery interventions including nutrition delivery and physical therapy to ensure functional recovery of COVID-19 patients.

We hypothesize: 1) COVID-19 will lead to significant, EE/metabolic changes, systemic mitochondrial dysfunction, significant muscle wasting and loss of function throughout the course of illness and during recovery. We hypothesize metabolic needs will initially decrease in acute illness and subsequently increase as patients transition from the acute phase of COVID illness to recovery phases. This data will guide nutrition and metabolic/clinical care in all phases of COVID-19 care where, for example, over-and under-feeding may pose risk to patient outcome. We hypothesize loss of muscle mass and physical function occurring in COVID-19 will significantly affect nutritional/rehabilitative/recovery of function/QoL needs and requires addressing to personalize care to optimize clinical and functional recovery efforts in older COVID-19 patients.

We believe longitudinal detailed indirect calorimetry with the innovative new Q-NRG device, cardiac assessment, body composition, and muscle and ultrasound measures in COVID-19 patients will play a key role in understanding and treating COVID-19 infection by providing objective data on the metabolic, cardiac, volume/fluid status, and nutrition needs of COVID-19 patients to the bedside clinician. This will increase our understanding of the pathophysiology of COVID-19 and the ability of clinical teams to optimize care and patient outcomes. These urgently needed data will lead to key advances in the clinical care of COVID-19 patients worldwide.

Recruiting
COVID-19

Device: Q-NRG Metobolic Cart 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)

Device: MuscleSound Ultrasound
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.
COVID-19 ICU Patients
ICU Patients (Control)
Other Name: Muscle Mass Ultrasound

Device: Multifrequency Bioimpedance Spectroscopy
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.
COVID-19 ICU Patients
ICU Patients (Control)
Other Name: InBody S10 BIA

Eligibility Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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%, 20%, 0.5°C,

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Duke University Medial Center
Durham, North Carolina, 27710

Recruiting

Investigator: Paul Wischmeyer, MD, EDIC, FASPEN, FCCM
Contact: 919-681-6437
paul.wischmeyer@duke.edu


Investigator: Jeroen Molinger
Contact: 9196816437
jeroen.molinger@duke.edu

Contacts

Paul E Wischmeyer, MD, EDIC, FASPEN, FCCM
919-681-6437
paul.wischmeyer@duke.edu

Jeroen Molinger
919-681-6437
Jeroen.molinger@duke.edu

Paul E Wischmeyer, MD, EDIC, FASPEN, FCCM
Principal Investigator
Duke University

Duke University
NCT Number
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