COVID-19NCT04350073
Longitudinal Energy Expenditure and Metabolic Effects in Patients With COVID-19 (LEEP-COVID)
An observational study of COVID-19, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Q-NRG Metobolic Cart Device, MuscleSound Ultrasound and Multifrequency Bioimpedance Spectroscopy
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2020to 22 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medial Center
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Q-NRG Metobolic Cart Device, MuscleSound Ultrasound, Multifrequency Bioimpedance Spectroscopy
- 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
- Medical subject headings
- COVID-19, Respiratory Insufficiency, Sarcopenia, Malnutrition, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-NRG Metobolic Cart DeviceDevice
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.
MuscleSound UltrasoundDevice
Also called Muscle Mass 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.
Multifrequency Bioimpedance SpectroscopyDevice
Also called InBody S10 BIA
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 ICU Patients | COVID-10 patients with respiratory failure admitted to the ICU Receives: 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 Receives: Device: Q-NRG Metobolic Cart Device; Device: MuscleSound Ultrasound; Device: Multifrequency Bioimpedance Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 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
Measures the change over time of (standard of care) CT-derived area of intramuscular muscle mass and adipose tissue in cm2
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start20 Apr 2020
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul E Wischmeyer, MD, EDIC, FASPEN, FCCM, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350073
- Sponsor's protocol ID
- Pro00105221
- Status last verified
- May 2023
- First submitted
- 14 Apr 2020
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Energy Expenditure and Metabolic Effects in Patients With COVID-19 (LEEP-COVID)
- ClinicalTrials.gov ID
- NCT04350073
- Acronym / sponsor ID
- Pro00105221
- Conditions
- COVID-19
- Keywords
- Respiratory failure, metabolic phenotype, mitochondrial phenotype, cardiometabolic phenotype, sarcopenia, malnutrition, critical care, muscle mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 ICU Patients | – | Device: Q-NRG Metobolic Cart Device, Device: MuscleSound Ultrasound, Device: Multifrequency Bioimpedance SpectroscopyCOVID-10 patients with respiratory failure admitted to the ICU |
| ICU Patients (Control) | – | Device: Q-NRG Metobolic Cart Device, Device: MuscleSound Ultrasound, Device: Multifrequency Bioimpedance SpectroscopyNon-COVID-19 respiratory failure patients requiring mechanical ventilation > 48 h receiving similar ICU standards of care at Duke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q-NRG Metobolic Cart DeviceCOVID-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 | COVID-19 ICU Patients, ICU Patients (Control) |
| MuscleSound UltrasoundAlso: Muscle Mass UltrasoundCOVID-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. | Device | COVID-19 ICU Patients, ICU Patients (Control) |
| Multifrequency Bioimpedance SpectroscopyAlso: InBody S10 BIACOVID-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. | Device | COVID-19 ICU Patients, ICU Patients (Control) |
Primary outcome
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)
4 secondary outcomes
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
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.)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul E Wischmeyer, MD, EDIC, FASPEN, FCCM principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.