The Early Rehabilitation Program in Post-LT Pts
The Safety and Efficacy of Early Rehabilitation Program in Immediate Liver Transplant Patients
1 other identifier
interventional
236
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
Typical duration for not_applicable
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
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedFirst Submitted
Initial submission to the registry
May 8, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedMay 18, 2018
May 1, 2018
1.5 years
May 8, 2018
May 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
ICU day (days)
up to 60 days
ventilator day (days)
up to 60 days
Secondary Outcomes (4)
Time to start rehabilitation from ICU admission (days)
up to 2 weeks
in-hospital LOS (days)
up to 24 weeks
hospital readmission rate after surgery (%)
1 year follow up from the surgery
1 year mortality rate (%)
1 year follow up from the surgery
Study Arms (2)
Pre-ERP
NO INTERVENTIONA group of patients who underwent liver transplantation surgery before the early rehabilitation program
Post-ERP
EXPERIMENTALA group of immediate liver transplant patients who had an early rehabilitation program in ICU care
Interventions
Deliver the one of 5-step early rehabilitation program for immediate liver transplant pts on weekday
Eligibility Criteria
You may qualify if:
- immediate post liver transplant patients
You may not qualify if:
- patients who transferred to sub-ICU within 72 hours re-liver transplantation case wound, mental problem post op bleeding unstable vital
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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: 16244526RESULTKothari 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: 27049779RESULTMaffei 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.
PMID: 28279659RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
May 8, 2018
First Posted
May 18, 2018
Study Start
October 1, 2014
Primary Completion
March 31, 2016
Study Completion
March 31, 2017
Last Updated
May 18, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share