The Early Rehabilitation Program in Post-LT Pts

NCT ID: NCT03529656

Last Updated: 2018-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-01

Study Completion Date

2017-03-31

Brief Summary

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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

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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).

Conditions

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ICU-acquired Weakness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pre-ERP

A group of patients who underwent liver transplantation surgery before the early rehabilitation program

Group Type NO_INTERVENTION

No interventions assigned to this group

Post-ERP

A group of immediate liver transplant patients who had an early rehabilitation program in ICU care

Group Type EXPERIMENTAL

Early rehabilitation program for liver transplantation

Intervention Type BEHAVIORAL

Deliver the one of 5-step early rehabilitation program for immediate liver transplant pts on weekday

Interventions

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Early rehabilitation program for liver transplantation

Deliver the one of 5-step early rehabilitation program for immediate liver transplant pts on weekday

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Suk-Kyung

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 16244526 (View on PubMed)

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.

Reference Type RESULT
PMID: 27049779 (View on PubMed)

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.

Reference Type RESULT
PMID: 28279659 (View on PubMed)

Other Identifiers

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AsanMC-LT rehab

Identifier Type: -

Identifier Source: org_study_id

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