Cardiovascular Surgical ProceduresNCT02463123
Energy Expenditure Estimation in Cardiac Surgery
An observational study of Cardiovascular Surgical Procedures and Intensive Care, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Estimation of energy requirements is essential for adequate nutritional support in ICU. Indirect calorimetry being the golden standard of resting energy expenditure estimation is not available in most intensive care units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Surgical Procedures, Intensive Care
- What is being tested?
- Indirect calorimetry
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 1 siteRussia
- Study dates
- May 2015to Jun 2017
- 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: Patients after cardiothoracic interventions using cardiopulmonary bypass
Who may be able to join
- Patient of cardiothoracic ICU
Who cannot join
- Shock
- patients on ECMO
- Hypoxemia <60 mmHg
- Active bleeding
- Ventilation with FiO2 >0.6
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resting Energy Expenditure in Cardiac Patients Operated Under Cardiopulmonary Bypass
Estimation of energy requirements is essential for adequate nutritional support in ICU. Indirect calorimetry being the golden standard of resting energy expenditure estimation is not available in most intensive care units. Different predictive equations have been developed, but not evaluated in cardiac population and have low accuracy in compare to the indirect calorimetry. The aim of present study is to develop cardio-specific equation for resting energy expenditure estimation.
- Conditions
- Cardiovascular Surgical Procedures, Intensive Care
- Being tested
- Indirect calorimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect calorimetryDevice
Resting energy expenditure will be studied using indirect calorimeter CCM Express (Medgraphics Inc, USA).
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting energy expenditure measured in kcal/day using indirect calorimetry
Measured: participants will be followed for the duration intensive care unit stay, an expected average 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Surgical ProceduresStudies of the same condition, open and under way.
- 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463123
- Sponsor's protocol ID
- 01.2015
- Status last verified
- Mar 2017
- First submitted
- 29 May 2015
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Efremov SM, Talaban VO, Ponomarev DN, Vedernikov PE, Chechenin MG, Artemieva VV, Lomivorotov VV. Development and Validation of a New Cardio-Specific Resting Energy Expenditure Equation for Adults. JPEN J Parenter Enteral Nutr. 2018 May;42(4):702-708. doi: 10.1177/0148607117711648. Epub 2017 Dec 19.
PubMed 28575581
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Energy Expenditure in Cardiac Patients Operated Under Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02463123
- Acronym / sponsor ID
- 01.2015
- Conditions
- Cardiovascular Surgical Procedures, Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- May 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 4 Jun 2015 (estimated)
- 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.
Estimation of energy requirements is essential for adequate nutritional support in ICU. Indirect calorimetry being the golden standard of resting energy expenditure estimation is not available in most intensive care units. Different predictive equations have been developed, but not evaluated in cardiac population and have low accuracy in compare to the indirect calorimetry. The aim of present study is to develop cardio-specific equation for resting energy expenditure estimation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after cardiothoracic interventions using cardiopulmonary bypass
Key inclusion criteria (1 listed)
- Patient of cardiothoracic ICU
Key exclusion criteria (5 listed)
- Shock
- patients on ECMO
- Hypoxemia <60 mmHg
- Active bleeding
- Ventilation with FiO2 >0.6
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 |
|---|---|---|
| Indirect calorimetryResting energy expenditure will be studied using indirect calorimeter CCM Express (Medgraphics Inc, USA). | Device | – |
Primary outcome
Resting energy expenditure measured in kcal/day using indirect calorimetry
Time frame: participants will be followed for the duration intensive care unit stay, an expected average 2 days
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 30 Aug 2017.
- Background: PubMed 28575581Efremov SM, Talaban VO, Ponomarev DN, Vedernikov PE, Chechenin MG, Artemieva VV, Lomivorotov VV. Development and Validation of a New Cardio-Specific Resting Energy Expenditure Equation for Adults. JPEN J Parenter Enteral Nutr. 2018 May;42(4):702-708. doi: 10.1177/0148607117711648. Epub 2017 Dec 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiovascular Surgical Procedures and Intensive Care, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 1 inclusion and 5 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 30 Aug 2017. 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 Russia. 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?
Resting energy expenditure measured in kcal/day using indirect calorimetry (time frame: participants will be followed for the duration intensive care unit stay, an expected average 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02463123, which also lists 1 linked publication.
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 30 Aug 2017; AzTrials last refreshed its copy on 31 Oct 2026.