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Completed

NCT Number: NCT03529656

The Early Rehabilitation Program in Post-LT Pts

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.

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Key information

Conditions

ICU-acquired Weakness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early rehabilitation program for liver transplantation

Behavioral

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

Primary outcomes

  1. ICU day (days)

    Time frame: up to 60 days

  2. ventilator day (days)

    Time frame: up to 60 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 18, 2018
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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