Liver Transplanted Patients Clinical Trial
Official title:
Early Rehabilitation Program is Feasible and Safe in ICU in Liver Transplanted Patients
Liver transplantation is the last surgical treatment for patients with acute or chronic
liver disease. Transplantation therapies technics are in constant evolution. It allows an
increasing survivals rates and time to come back to daily activities. The postoperative
treatment after abdominal surgery as Liver Transplantation (LT) is usually performed in
Intensive Care Unit (ICU).This postoperative phase is one of the most important steps
regarding the involvement of the rehabilitation of the patient (Rongies 2005). Physical
abilities transplantation are likely to be important in the postoperative. It appears that
pre-transplant subjects have a weakened muscle potential, they will increase it
significantly in the months after transplantation with a rehabilitation program adapted
(Beyer 1999). Length of stay in ICU depends on surgery complications. Inactivity induced by
sedation and ICU length of stay are major factor for increasing complications as respiratory
disorders and muscle weakness. Several studies have reported feasibility and safety an early
mobility program in ICU, especially regarding the length of stay decrease (Bailey 2007;
Morris 2008; Schweickret 2009, Needham 2010; Bourdin 2010) These early mobility programs
encompass muscle strength assessment, passive range of motion, active mobility, sitting on
the edge of bed, standing and walking, which would be related to the primary disease of LT
(Rongies 2008). The assessment of the strength for ICU patient is feasible and reproducible
with the Medical Research Council score (MRC score). The MRC score consists in an assessment
of three muscle groups of upper and lower limbs. Sitting positions and verticalization are
included in programs begun as soon as possible after surgery evaluation of the response
level to verbal stimulation and physical abilities (Gosselink 2011). The skills of the
physiotherapist are established in legal texts making him a key in the assessment and
management of these patients on musculoskeletal and respiratory domains.
The purpose of this study is to validate data feasibility and tolerance. Another aim is also
to assess the length of stay in ICU, of early mobility and physical program, started in the
postoperative period in a population of patients with liver transplantation, during their
stay in ICU of Prof. Albanese. Thus, we decided to carry out a parallel study, open,
randomized monocentric comparing two groups of patient liver transplanted. The control group
will receive the standard treatment used in the ICU and the experimental group will receive
a protocol of early mobilization according to data from recent literature on the subject.
The study is scheduled to last over one year and included patients will receive physical
therapy on five days a week with a frequency of one to several times per day depending on
the clinical requirements or conditions of the study.
| Status | Active, not recruiting |
| Enrollment | 40 |
| Est. completion date | April 2015 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patient more than 18 years, - patient for a liver transplant - patient that informed consent was obtained Exclusion Criteria: - patient whose consent has not been obtained, - patient with major cons-indications to the application program (paralysis neuromyopathy majeure), - patient with hemodynamic instability or severe infection, - pregnant women, - nursing mothers, - persons deprived of their liberty by a judicial or administrative decision, - patient being a measure of legal protection, - patient requiring a transplant urgently - patient younger than 18 years. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Medical Research Council score (MRC score). | The assessment of the strength for ICU patient | 12 months | No |
| Secondary | the length of stay in ICU, | 12 months | No |