The Early Rehabilitation Program in Post-LT Pts

May 17, 2018 updated by: Suk-Kyung, Asan Medical Center

The Safety and Efficacy of Early Rehabilitation Program in Immediate Liver Transplant Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-ERP
A group of patients who underwent liver transplantation surgery before the early rehabilitation program
Experimental: Post-ERP
A group of immediate liver transplant patients who had an early rehabilitation program in ICU care
Behavioral: Early rehabilitation program for liver transplantation
Deliver the one of 5-step early rehabilitation program for immediate liver transplant pts on weekday

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ICU day (days)
Time Frame: up to 60 days
up to 60 days
ventilator day (days)
Time Frame: up to 60 days
up to 60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to start rehabilitation from ICU admission (days)
Time Frame: up to 2 weeks
up to 2 weeks
in-hospital LOS (days)
Time Frame: up to 24 weeks
up to 24 weeks
hospital readmission rate after surgery (%)
Time Frame: 1 year follow up from the surgery
1 year follow up from the surgery
1 year mortality rate (%)
Time Frame: 1 year follow up from the surgery
1 year follow up from the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

March 31, 2016

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 18, 2018

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AsanMC-LT rehab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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