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

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ClinicalTrials.gov Identifier: NCT04350073
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date April 14, 2020
First Posted Date April 16, 2020
Last Update Posted Date October 25, 2021
Actual Study Start Date April 20, 2020
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2020)
  • 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 19, 2021)
  • 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) ]
Original Secondary Outcome Measures
 (submitted: April 15, 2020)
  • 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 [ Time Frame: 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 [ Time Frame: 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 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 [ Time Frame: 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 [ Time Frame: 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Longitudinal Energy Expenditure and Metabolic Effects in Patients With COVID-19 (LEEP-COVID)
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition COVID-19
Intervention
  • 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.
  • 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.
    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.
    Other Name: InBody S10 BIA
Study Groups/Cohorts
  • COVID-19 ICU Patients
    COVID-10 patients with respiratory failure admitted to the ICU
    Interventions:
    • 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
    Interventions:
    • Device: Q-NRG Metobolic Cart Device
    • Device: MuscleSound Ultrasound
    • Device: Multifrequency Bioimpedance Spectroscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 15, 2020)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2022
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
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%, <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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Paul E Wischmeyer, MD, EDIC, FASPEN, FCCM 919-681-6437 paul.wischmeyer@duke.edu
Contact: Jeroen Molinger 919-681-6437 Jeroen.molinger@duke.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04350073
Other Study ID Numbers Pro00105221
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators
Principal Investigator: Paul E Wischmeyer, MD, EDIC, FASPEN, FCCM Duke University
PRS Account Duke University
Verification Date October 2021