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

Completed

• Conditions: COVID-19
• Interventions: Device: Q-NRG Metobolic Cart Device; Device: MuscleSound Ultrasound; Device: Multifrequency Bioimpedance Spectroscopy

• Registration Number: NCT04350073
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-16
• Study Start: 2020-04-20
• Primary Completion: 2022-08-22
• Study Completion: 2022-08-22
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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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%, <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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 ICU Patients	Q-NRG Metobolic Cart Device	COVID-10 patients with respiratory failure admitted to the ICU
COVID-19 ICU Patients	MuscleSound Ultrasound	COVID-10 patients with respiratory failure admitted to the ICU
ICU Patients (Control)	MuscleSound Ultrasound	Non-COVID-19 respiratory failure patients requiring mechanical ventilation \> 48 h receiving similar ICU standards of care at Duke
ICU Patients (Control)	Multifrequency Bioimpedance Spectroscopy	Non-COVID-19 respiratory failure patients requiring mechanical ventilation \> 48 h receiving similar ICU standards of care at Duke
COVID-19 ICU Patients	Multifrequency Bioimpedance Spectroscopy	COVID-10 patients with respiratory failure admitted to the ICU
ICU Patients (Control)	Q-NRG Metobolic Cart Device	Non-COVID-19 respiratory failure patients requiring mechanical ventilation \> 48 h receiving similar ICU standards of care at Duke

Primary Outcome Measures

Name	Time	Method
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	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)	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.
Metabolic and Nutritional Needs of COVID-19 Patients:Changes of the Respiratory Exchange Ratio (RER) as measured by the indirect calorimetry Q-NRG device	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)	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
Cardiac Output and Cardiac Measures (non-invasive) in COVID-19 patients	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)	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)

Secondary Outcome Measures

Name	Time	Method
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	Measures the change over time of (standard of care) CT-derived area of intramuscular muscle mass and adipose tissue in cm2
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.)	The change over time of Ultrasound-derived muscle mass, muscle glycogen, and area of intramuscular adipose tissue in % and intramuscular glycogen content (IMGC) from rectus femurs - vastus laterals - intercostalis - temporalis - styloglossys
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)

Trial Locations

Locations (1)

Duke University Medial Center; 🇺🇸 Durham, North Carolina, United States