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The Early Rehabilitation Program in Post-LT Pts

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ClinicalTrials.gov Identifier: NCT03529656
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Suk-Kyung, 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.

Condition or disease Intervention/treatment Phase
ICU-acquired Weakness Behavioral: Early rehabilitation program for liver transplantation Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Safety and Efficacy of Early Rehabilitation Program in Immediate Liver Transplant Patients
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. ICU day (days) [ Time Frame: up to 60 days ]
  2. ventilator day (days) [ Time Frame: up to 60 days ]

Secondary Outcome Measures :
  1. Time to start rehabilitation from ICU admission (days) [ Time Frame: up to 2 weeks ]
  2. in-hospital LOS (days) [ Time Frame: up to 24 weeks ]
  3. hospital readmission rate after surgery (%) [ Time Frame: 1 year follow up from the surgery ]
  4. 1 year mortality rate (%) [ Time Frame: 1 year follow up from the surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications of Results:
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Responsible Party: Suk-Kyung, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03529656     History of Changes
Other Study ID Numbers: AsanMC-LT rehab
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Suk-Kyung, Asan Medical Center:
Liver transplantation
rehabilitation
ICU acquired weakness

Additional relevant MeSH terms:
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Liver Extracts
Hematinics