Metabolism RequirementNCT04132700
Longitudinal Evaluation of Energy Expenditure in ICU Patients From Admission to Discharge Using A Novel Indirect Calorimeter: LEEP-Forward Trial
A study testing Q-NRG Metobolic Cart Device in people with Metabolism Requirement and Energy Requirement, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to utilize the new indirect calorimetry Q-NRG device to the measurement of energy expenditure (EE) throughout your intensive care unit (ICU) stay and ultimately address fundamental questions about metabolism and energy requirements for critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolism Requirement, Energy Requirement, Indirect Calorimetry
- What is being tested?
- Q-NRG Metobolic Cart Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2020to 1 Nov 2020
- Phase
- Interventional
- 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
Who may be able to join
- Critically ill patients requiring mechanical ventilation for > 48 hours
- Patients admitted to Duke Surgical/Trauma ICU, Medical ICU, Cardiothoracic ICU, and Neuro ICU
- Patients must be enrolled within 72 hours of ICU admission
Who cannot join
- 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)
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- 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
- Continuous Renal Replacement Therapy (CRRT/CVVH that does not experience an appropriate interruption of at least 60 minutes to allow for indirect calorimetry measurements
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of this study is to utilize the new indirect calorimetry Q-NRG device to the measurement of energy expenditure (EE) throughout your intensive care unit (ICU) stay and ultimately address fundamental questions about metabolism and energy requirements for critically ill patients. The study will use a new, investigational calorimeter called the Q-NRG (the study device, supplied by Cosmed, Italy). The word "investigational" means the study drug or device or biologic is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). A calorimeter is a device that connects to your breathing machine tubing for a short period (about 30 minutes) and helps to determine what nutrition you may need in your current condition.
There are FDA approved calorimeters that have been used as the current standard of care. These devices and the new Q-NRG calorimeter measure oxygen consumption and carbon dioxide production (the gas you breathe out when you exhale) and calculate energy expenditure. Unfortunately, previously existing calorimeters are complicated to use, cumbersome and require time for measurements. It is hoped the new calorimeter will be easier and more practical to use and, through the measurements we take, we will have a better understanding of a patient's caloric needs for healing.
Muscle mass and quality play a role in determining EE and metabolic needs. Massive loss of muscle mass and quality that occurs in critical illness significantly affects EE and nutritional needs and should be accounted for in clinical nutrition delivery. Imaging (standard of care abdominal CT and MSK ultrasound) will be used to assess muscle mass, and muscle quality (amount of intramuscular adipose content; IMAT).
- Being tested
- Q-NRG Metobolic Cart Device
- Keywords
- energy expenditure, respiratory quotient, Intensive Care Unit (ICU), indirect calorimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-NRG Metobolic Cart DeviceDevice
ICU pateints 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.
| Study group | Role | What they receive |
|---|---|---|
| ICU Patients | Experimental | Patients admitted to the ICU will be monitored using the Q-NRG for up to 30 mins. Receives: Device: Q-NRG Metobolic Cart Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
Secondary outcomes (2)
Changes of Intramuscular adipose tissue (IMAT) content from the psoas at the Level of L3/Th3
the change over time of CT-derived area of intramuscular adipose tissue in cm2
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)
Changes of Intramuscular adipose tissue (IMAT) from rectus femurs - vastus laterals - temporalis - styloglossys
the change over time of Ultrasound-derived area of intramuscular adipose tissue in %
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 posted21 Oct 2019
- Study start15 Mar 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Why it stopped: LEEP-COVID study (NCT04350073) initiation enables inclusion of COVID-positive subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism RequirementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Wischmeyer, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132700
- Sponsor's protocol ID
- Pro00103738
- Status last verified
- Nov 2019
- First submitted
- 17 Oct 2019
- Last updated
- 21 May 2021
- 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 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Energy Expenditure in ICU Patients From Admission to Discharge Using A Novel Indirect Calorimeter: LEEP-Forward Trial
- ClinicalTrials.gov ID
- NCT04132700
- Acronym / sponsor ID
- Pro00103738
- Keywords
- energy expenditure, respiratory quotient, Intensive Care Unit (ICU), indirect calorimetry
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: LEEP-COVID study (NCT04350073) initiation enables inclusion of COVID-positive subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 21 Oct 2019 (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.
The purpose of this study is to utilize the new indirect calorimetry Q-NRG device to the measurement of energy expenditure (EE) throughout your intensive care unit (ICU) stay and ultimately address fundamental questions about metabolism and energy requirements for critically ill patients. The study will use a new, investigational calorimeter called the Q-NRG (the study device, supplied by Cosmed, Italy). The word "investigational" means the study drug or device or biologic is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). A calorimeter is a device that connects to your breathing machine tubing for a short period (about 30 minutes) and helps to determine what nutrition you may need in your current condition.
There are FDA approved calorimeters that have been used as the current standard of care. These devices and the new Q-NRG calorimeter measure oxygen consumption and carbon dioxide production (the gas you breathe out when you exhale) and calculate energy expenditure. Unfortunately, previously existing calorimeters are complicated to use, cumbersome and require time for measurements. It is hoped the new calorimeter will be easier and more practical to use and, through the measurements we take, we will have a better understanding of a patient's caloric needs for healing.
Muscle mass and quality play a role in determining EE and metabolic needs. Massive loss of muscle mass and quality that occurs in critical illness significantly affects EE and nutritional needs and should be accounted for in clinical nutrition delivery. Imaging (standard of care abdominal CT and MSK ultrasound) will be used to assess muscle mass, and muscle quality (amount of intramuscular adipose content; IMAT).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Patients | Experimental | Device: Q-NRG Metobolic Cart DevicePatients admitted to the ICU will be monitored using the Q-NRG for up to 30 mins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Critically ill patients requiring mechanical ventilation for > 48 hours
- Patients admitted to Duke Surgical/Trauma ICU, Medical ICU, Cardiothoracic ICU, and Neuro ICU
- Patients must be enrolled within 72 hours of ICU admission
Key exclusion criteria (10 listed)
- 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)
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 DeviceICU pateints 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 | ICU Patients |
Primary outcome
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.
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
2 secondary outcomes
Changes of Intramuscular adipose tissue (IMAT) content from the psoas at the Level of L3/Th3
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)
Changes of Intramuscular adipose tissue (IMAT) from rectus femurs - vastus laterals - temporalis - styloglossys
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- 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 Wischmeyer 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?
A study testing Q-NRG Metobolic Cart Device in people with Metabolism Requirement and Energy Requirement, 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: withdrawn, as of the sponsor's last update on 21 May 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
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 2 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 21 May 2021.