Using Indirect Calorimetry for Liver Transplants Patients

Indirect Calorimetry Clinical Trial

Official title:

Assessing the Appropriate Energy Expenditure Requirement Using Indirect Calorimetry for Liver Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622268
• Other study ID #: AsanMC-LTindirectKcal
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Therefore, precise measurements using indirect calorimetry may be helpful when treating critically ill patients to avoid underestimating or overestimating their metabolic needs.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• mechanically ventilated patients who had received liver transplants and were expected to stay in the ICU more than 2 days were studied.

Exclusion Criteria:

• Refusal

• patients who were extubated before 36 hrs

Related Conditions & MeSH terms

• Indirect Calorimetry

Locations

Country	Name	City	State
Korea, Republic of	Hakjae Lee	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Kross 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. — View Citation

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. Review. — View Citation

Sundström M, Tjäder 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. — View Citation

Xiao 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year