Clinical trial NCT03529656: 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
Overall status: COMPLETED
Phase: NA
Conditions: ICU-acquired Weakness
Keywords: Liver transplantation
rehabilitation
ICU acquired weakness
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: ICU day (days)
timeFrame: up to 60 days
measure: ventilator day (days)
timeFrame: up to 60 days
Secondary outcomes:
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
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.