The Safety and Efficacy of Early Rehabilitation Program in Immediate Liver Transplant Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 236
- Primary Endpoint
- ICU day (days)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
ICU day (days)
Time Frame: up to 60 days
ventilator day (days)
Time Frame: up to 60 days
Secondary Outcomes
- hospital readmission rate after surgery (%)(1 year follow up from the surgery)
- 1 year mortality rate (%)(1 year follow up from the surgery)
- Time to start rehabilitation from ICU admission (days)(up to 2 weeks)
- in-hospital LOS (days)(up to 24 weeks)
Investigators
Suk-Kyung
Associate professor
Asan Medical Center