Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT03529656
Status:
COMPLETED
Last Update Posted:
2018-05-18
First Post:
2018-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Early Rehabilitation Program in Post-LT Pts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-17', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU day (days)', 'timeFrame': 'up to 60 days'}, {'measure': 'ventilator day (days)', 'timeFrame': 'up to 60 days'}], 'secondaryOutcomes': [{'measure': 'Time to start rehabilitation from ICU admission (days)', 'timeFrame': 'up to 2 weeks'}, {'measure': 'in-hospital LOS (days)', 'timeFrame': 'up to 24 weeks'}, {'measure': 'hospital readmission rate after surgery (%)', 'timeFrame': '1 year follow up from the surgery'}, {'measure': '1 year mortality rate (%)', 'timeFrame': '1 year follow up from the surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver transplantation', 'rehabilitation', 'ICU acquired weakness'], 'conditions': ['ICU-acquired Weakness']}, 'referencesModule': {'references': [{'pmid': '16244526', 'type': 'RESULT', 'citation': 'Cortazzo MH, Helkowski W, Pippin B, Boninger ML, Zafonte R. Acute inpatient rehabilitation of 55 patients after liver transplantation. Am J Phys Med Rehabil. 2005 Nov;84(11):880-4. doi: 10.1097/01.phm.0000184093.53032.ed.'}, {'pmid': '27049779', 'type': 'RESULT', 'citation': 'Kothari AN, Yau RM, Blackwell RH, Schaidle-Blackburn C, Markossian T, Zapf MA, Lu AD, Kuo PC. Inpatient Rehabilitation after Liver Transplantation Decreases Risk and Severity of 30-Day Readmissions. J Am Coll Surg. 2016 Jul;223(1):164-171.e2. doi: 10.1016/j.jamcollsurg.2016.01.061. Epub 2016 Feb 13.'}, {'pmid': '28279659', 'type': 'RESULT', 'citation': 'Maffei P, Wiramus S, Bensoussan L, Bienvenu L, Haddad E, Morange S, Fathallah M, Hardwigsen J, Viton JM, Le Treut YP, Albanese J, Gregoire E. Intensive Early Rehabilitation in the Intensive Care Unit for Liver Transplant Recipients: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1518-1525. doi: 10.1016/j.apmr.2017.01.028. Epub 2017 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an early rehabilitation program for immediate liver transplant patients is safe and effective in preventing critical care illness and intensive care unit acquired weakness.', 'detailedDescription': 'Patients with liver transplantation (LT) have poor general condition before surgery and require ICU care for a certain period. For those patients, the side effects of ICU care such as intensive care unit-acquired weakness (ICU-AW), critical illness polyneuropathy (CIP) are well known. Therefore, we access the safety and efficacy of early rehabilitation program (ERP) in liver transplant recipients.\n\nPatients were retrospectively selected for the Pre-ERP group (2014.05-2014.10) and for the Post-ERP group (2015.10-2016.03). During the period of 6 months, 136 patients and 100 patients underwent LT, and 65, 62 patients were enrolled after exclusion. Forty patients from the each group were compared after propensity score matching (PSM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* immediate post liver transplant patients\n\nExclusion Criteria:\n\n* patients who transferred to sub-ICU within 72 hours re-liver transplantation case wound, mental problem post op bleeding unstable vital'}, 'identificationModule': {'nctId': 'NCT03529656', 'briefTitle': 'The Early Rehabilitation Program in Post-LT Pts', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'The Safety and Efficacy of Early Rehabilitation Program in Immediate Liver Transplant Patients', 'orgStudyIdInfo': {'id': 'AsanMC-LT rehab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Pre-ERP', 'description': 'A group of patients who underwent liver transplantation surgery before the early rehabilitation program'}, {'type': 'EXPERIMENTAL', 'label': 'Post-ERP', 'description': 'A group of immediate liver transplant patients who had an early rehabilitation program in ICU care', 'interventionNames': ['Behavioral: Early rehabilitation program for liver transplantation']}], 'interventions': [{'name': 'Early rehabilitation program for liver transplantation', 'type': 'BEHAVIORAL', 'description': 'Deliver the one of 5-step early rehabilitation program for immediate liver transplant pts on weekday', 'armGroupLabels': ['Post-ERP']}]}, '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'}}}}