Back to resultsThe Early Rehabilitation Program in Post-LT Pts
Primary Purpose
ICU-acquired Weakness
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early rehabilitation program for liver transplantation
Sponsored by
About this trial
This is an interventional supportive care trial for ICU-acquired Weakness focused on measuring Liver transplantation, rehabilitation, ICU acquired weakness
Eligibility Criteria
Inclusion Criteria:
- immediate post liver transplant patients
Exclusion Criteria:
- patients who transferred to sub-ICU within 72 hours re-liver transplantation case wound, mental problem post op bleeding unstable vital
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Pre-ERP
Post-ERP
Arm Description
A group of patients who underwent liver transplantation surgery before the early rehabilitation program
A group of immediate liver transplant patients who had an early rehabilitation program in ICU care
Outcomes
Primary Outcome Measures
ICU day (days)
ventilator day (days)
Secondary Outcome Measures
Time to start rehabilitation from ICU admission (days)
in-hospital LOS (days)
hospital readmission rate after surgery (%)
1 year mortality rate (%)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03529656
Brief Title
The Early Rehabilitation Program in Post-LT Pts
Official Title
The Safety and Efficacy of Early Rehabilitation Program in Immediate Liver Transplant Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
Patients 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU-acquired Weakness
Keywords
Liver transplantation, rehabilitation, ICU acquired weakness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-ERP
Arm Type
No Intervention
Arm Description
A group of patients who underwent liver transplantation surgery before the early rehabilitation program
Arm Title
Post-ERP
Arm Type
Experimental
Arm Description
A group of immediate liver transplant patients who had an early rehabilitation program in ICU care
Intervention Type
Behavioral
Intervention Name(s)
Early rehabilitation program for liver transplantation
Intervention Description
Deliver the one of 5-step early rehabilitation program for immediate liver transplant pts on weekday
Primary Outcome Measure Information:
Title
ICU day (days)
Time Frame
up to 60 days
Title
ventilator day (days)
Time Frame
up to 60 days
Secondary Outcome Measure Information:
Title
Time to start rehabilitation from ICU admission (days)
Time Frame
up to 2 weeks
Title
in-hospital LOS (days)
Time Frame
up to 24 weeks
Title
hospital readmission rate after surgery (%)
Time Frame
1 year follow up from the surgery
Title
1 year mortality rate (%)
Time Frame
1 year follow up from the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
immediate post liver transplant patients
Exclusion Criteria:
patients who transferred to sub-ICU within 72 hours re-liver transplantation case wound, mental problem post op bleeding unstable vital
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16244526
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.
Results Reference
result
PubMed Identifier
27049779
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.
Results Reference
result
PubMed Identifier
28279659
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.
Results Reference
result
Learn more about this trial
The Early Rehabilitation Program in Post-LT Pts
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