Indirect CalorimetryNCT03622268
Using Indirect Calorimetry for Liver Transplants Patients
An observational study of Indirect Calorimetry, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Although predicted REE calculated using the Penn state 1988 method agreed (ICC 0.61, p=0.00014) with the measured REE, all three predictive equations had a fixed bias and appeared to be inaccurate for predicting REE for liver transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indirect Calorimetry
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2017to 1 Aug 2018
- 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 who had received liver transplants
Who may be able to join
- mechanically ventilated patients who had received liver transplants and were expected to stay in the ICU more than 2 days were studied.
Who cannot join
- Refusal
- patients who were extubated before 36 hrs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Appropriate Energy Expenditure Requirement Using Indirect Calorimetry for Liver Transplant Recipients
Although predicted REE calculated using the Penn state 1988 method agreed (ICC 0.61, p=0.00014) with the measured REE, all three predictive equations had a fixed bias and appeared to be inaccurate for predicting REE for liver transplant recipients.
Therefore, precise measurements using indirect calorimetry may be helpful when treating critically ill patients to avoid underestimating or overestimating their metabolic needs.
Read the detailed description
Rationale: The aim of this study was to compare predictive equations with indirect calorimetry and identify the appropriate energy expenditure requirement of liver transplant(LT) recipients in South Korea.
Methods: This prospective observational study was conducted in a surgical ICU in an academic tertiary hospital over three months. Thirty mechanically ventilated patients who had received liver transplants and were expected to stay in the ICU more than 2 days were studied. Resting energy expenditure(REE) was measured 48 hours after ICU admission using open-circuit indirect calorimetry. Theoretical REE was estimated using three predictive equations: Harris-Benedict methods, lreton-Jones ventilated, and Penn state 1988. The REEs derived from each predictive equation were compared with the measured REE using an intraclass correlation coefficient (ICC) and a Bland-Altman plot.
- Conditions
- Indirect Calorimetry
- Keywords
- indirect calorimetry, energy expenditure assessment, intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Indirect calorimetry measurement | Using indirect calorimetry for measure resting energy expenditure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing REE with the measurement for each predictive equation and indirect calorimetry
The REEs derived from each predictive equation were compared with the measured REE using an intraclass correlation coefficient (ICC) and a Bland-Altman plot.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Dec 2017
- Primary completion1 May 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Indirect CalorimetryStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suk-Kyung, Asan Medical Center
- Investigators
- Suk-kyung Hong, Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622268
- Sponsor's protocol ID
- AsanMC-LTindirectKcal
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McClave SA, Martindale RG, Kiraly L. The use of indirect calorimetry in the intensive care unit. Curr Opin Clin Nutr Metab Care. 2013 Mar;16(2):202-8. doi: 10.1097/MCO.0b013e32835dbc54.
PubMed 23340008Sundstrom M, Tjader I, Rooyackers O, Wernerman J. Indirect calorimetry in mechanically ventilated patients. A systematic comparison of three instruments. Clin Nutr. 2013 Feb;32(1):118-21. doi: 10.1016/j.clnu.2012.06.004. Epub 2012 Jul 3.
PubMed 22763268Kross EK, Sena M, Schmidt K, Stapleton RD. A comparison of predictive equations of energy expenditure and measured energy expenditure in critically ill patients. J Crit Care. 2012 Jun;27(3):321.e5-12. doi: 10.1016/j.jcrc.2011.07.084. Epub 2012 Mar 14.
PubMed 22425340Xiao GZ, Su L, Duan PK, Wang QX, Huang Y. [Comparison of measuring energy expenditure with indirect calorimetry and traditional estimation of energy expenditure in patients in intensive care unit]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2011 Jul;23(7):392-5. Chinese.
PubMed 21787465
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Appropriate Energy Expenditure Requirement Using Indirect Calorimetry for Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT03622268
- Acronym / sponsor ID
- AsanMC-LTindirectKcal
- Conditions
- Indirect Calorimetry
- Keywords
- indirect calorimetry, energy expenditure assessment, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 9 Aug 2018 (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.
Although predicted REE calculated using the Penn state 1988 method agreed (ICC 0.61, p=0.00014) with the measured REE, all three predictive equations had a fixed bias and appeared to be inaccurate for predicting REE for liver transplant recipients.
Therefore, precise measurements using indirect calorimetry may be helpful when treating critically ill patients to avoid underestimating or overestimating their metabolic needs.
Detailed description
Rationale: The aim of this study was to compare predictive equations with indirect calorimetry and identify the appropriate energy expenditure requirement of liver transplant(LT) recipients in South Korea.
Methods: This prospective observational study was conducted in a surgical ICU in an academic tertiary hospital over three months. Thirty mechanically ventilated patients who had received liver transplants and were expected to stay in the ICU more than 2 days were studied. Resting energy expenditure(REE) was measured 48 hours after ICU admission using open-circuit indirect calorimetry. Theoretical REE was estimated using three predictive equations: Harris-Benedict methods, lreton-Jones ventilated, and Penn state 1988. The REEs derived from each predictive equation were compared with the measured REE using an intraclass correlation coefficient (ICC) and a Bland-Altman plot.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indirect calorimetry measurement | – | –Using indirect calorimetry for measure resting energy expenditure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had received liver transplants
Key inclusion criteria (1 listed)
- mechanically ventilated patients who had received liver transplants and were expected to stay in the ICU more than 2 days were studied.
Key exclusion criteria (2 listed)
- Refusal
- patients who were extubated before 36 hrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparing REE with the measurement for each predictive equation and indirect calorimetry
Time frame: 1 year
The REEs derived from each predictive equation were compared with the measured REE using an intraclass correlation coefficient (ICC) and a Bland-Altman plot.
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 9 Aug 2018.
- Results publication: PubMed 23340008McClave SA, Martindale RG, Kiraly L. The use of indirect calorimetry in the intensive care unit. Curr Opin Clin Nutr Metab Care. 2013 Mar;16(2):202-8. doi: 10.1097/MCO.0b013e32835dbc54.
- Results publication: PubMed 22763268Sundstrom M, Tjader I, Rooyackers O, Wernerman J. Indirect calorimetry in mechanically ventilated patients. A systematic comparison of three instruments. Clin Nutr. 2013 Feb;32(1):118-21. doi: 10.1016/j.clnu.2012.06.004. Epub 2012 Jul 3.
- Results publication: PubMed 22425340Kross EK, Sena M, Schmidt K, Stapleton RD. A comparison of predictive equations of energy expenditure and measured energy expenditure in critically ill patients. J Crit Care. 2012 Jun;27(3):321.e5-12. doi: 10.1016/j.jcrc.2011.07.084. Epub 2012 Mar 14.
- Results publication: PubMed 21787465Xiao GZ, Su L, Duan PK, Wang QX, Huang Y. [Comparison of measuring energy expenditure with indirect calorimetry and traditional estimation of energy expenditure in patients in intensive care unit]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2011 Jul;23(7):392-5. Chinese.
- 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.
Suk-kyung Hong, Ph.D. principal investigator
Asan Medical Center
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 Indirect Calorimetry, run by Asan Medical Center at 1 site in South Korea.
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 2 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 9 Aug 2018. 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 South Korea. 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?
Comparing REE with the measurement for each predictive equation and indirect calorimetry (time frame: 1 year). 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 NCT03622268, which also lists 4 linked publications.
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 9 Aug 2018.