The Early Rehabilitation Program in Post-LT Pts

ICU-acquired Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529656
• Other study ID #: AsanMC-LT rehab
• Status: Completed
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: March 31, 2017

Study information

• Verified date: May 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ICU-acquired Weakness

Intervention

Behavioral:
• Early rehabilitation program for liver transplantation
Deliver the one of 5-step early rehabilitation program for immediate liver transplant pts on weekday

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

References & Publications (3)

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. — View Citation

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 — View Citation

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 Controlle — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU day (days)		up to 60 days
Primary	ventilator day (days)		up to 60 days
Secondary	Time to start rehabilitation from ICU admission (days)		up to 2 weeks
Secondary	in-hospital LOS (days)		up to 24 weeks
Secondary	hospital readmission rate after surgery (%)		1 year follow up from the surgery
Secondary	1 year mortality rate (%)		1 year follow up from the surgery