Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT03622268
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2018-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Indirect Calorimetry for Liver Transplants Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2018-08-03', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing REE with the measurement for each predictive equation and indirect calorimetry', 'timeFrame': '1 year', 'description': 'The REEs derived from each predictive equation were compared with the measured REE using an intraclass correlation coefficient (ICC) and a Bland-Altman plot.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['indirect calorimetry', 'energy expenditure assessment', 'intensive care unit'], 'conditions': ['Indirect Calorimetry']}, 'referencesModule': {'references': [{'pmid': '23340008', 'type': 'RESULT', '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.'}, {'pmid': '22763268', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '22425340', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '21787465', 'type': 'RESULT', '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):392-5. Chinese.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nTherefore, precise measurements using indirect calorimetry may be helpful when treating critically ill patients to avoid underestimating or overestimating their metabolic needs.', 'detailedDescription': '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.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had received liver transplants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mechanically ventilated patients who had received liver transplants and were expected to stay in the ICU more than 2 days were studied.\n\nExclusion Criteria:\n\n* Refusal\n* patients who were extubated before 36 hrs'}, 'identificationModule': {'nctId': 'NCT03622268', 'briefTitle': 'Using Indirect Calorimetry for Liver Transplants Patients', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Assessing the Appropriate Energy Expenditure Requirement Using Indirect Calorimetry for Liver Transplant Recipients', 'orgStudyIdInfo': {'id': 'AsanMC-LTindirectKcal'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Indirect calorimetry measurement', 'description': 'Using indirect calorimetry for measure resting energy expenditure'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hakjae Lee', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Suk-kyung Hong, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Suk-Kyung', 'investigatorAffiliation': 'Asan Medical Center'}}}}