Using Indirect Calorimetry for Liver Transplants Patients

August 7, 2018 updated by: Suk-Kyung, Asan Medical Center

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who had received liver transplants

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Indirect calorimetry measurement
Using indirect calorimetry for measure resting energy expenditure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Suk-kyung Hong, Ph.D., Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AsanMC-LTindirectKcal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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