NCT03622268

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

August 3, 2018

Last Update Submit

August 7, 2018

Conditions

Keywords

indirect calorimetryenergy expenditure assessmentintensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Indirect calorimetry measurement

Using indirect calorimetry for measure resting energy expenditure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who had received liver transplants

You may qualify if:

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

You may not qualify if:

  • Refusal
  • patients who were extubated before 36 hrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hakjae Lee

Seoul, South Korea

Location

Related Publications (4)

  • 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.

  • Sundstrom 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.

  • 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.

  • 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):392-5. Chinese.

Study Officials

  • Suk-kyung Hong, Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 3, 2018

First Posted

August 9, 2018

Study Start

December 1, 2017

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations