跳至主要内容
临床试验/NCT03529656
NCT03529656已完成不适用

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

Asan Medical Center0 个研究点目标入组 236 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
236
主要终点
ICU day (days)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •immediate post liver transplant patients

排除标准

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

研究组 & 干预措施

Pre-ERP

No Intervention

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

Post-ERP

Experimental

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

干预措施: Early rehabilitation program for liver transplantation (Behavioral)

结局指标

主要结局

ICU day (days)

时间窗: up to 60 days

ventilator day (days)

时间窗: up to 60 days

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suk-Kyung

Associate professor

Asan Medical Center

相似试验