The Early Rehabilitation Program in Post-LT Pts

Not Applicable

Completed

• Conditions: ICU-acquired Weakness
• Interventions: Behavioral: Early rehabilitation program for liver transplantation

• Registration Number: NCT03529656
• Lead Sponsor: Asan Medical Center

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 Timeline

• Study Start: 2014-10-01
• Primary Completion: 2016-03-31
• Study Completion: 2017-03-31
• Status Verified: 2018-05
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-17
• Last Update Submitted: 2018-05-17
• Study First Posted: 2018-05-18
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• immediate post liver transplant patients

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Exclusion Criteria

• patients who transferred to sub-ICU within 72 hours re-liver transplantation case wound, mental problem post op bleeding unstable vital

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-ERP	Early rehabilitation program for liver transplantation	A group of immediate liver transplant patients who had an early rehabilitation program in ICU care

Primary Outcome Measures

Name	Time	Method
ICU day (days)	up to 60 days
ventilator day (days)	up to 60 days

Secondary Outcome Measures

Name	Time	Method
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