BIA Assessment of Polymyoneuropathy in Critically Ill Patients

Study Overview
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Brief Summary
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The aim of the study is to monitor and evaluate changes in body composition, with a special emphasis on muscle mass, in the context of polyneuromyopathy of critically-ill patients at ICU, on artificial ventilation (duration of artificial ventilation at least 7 days), and subsequent comparison with the patient's condition in 12 weeks, as a part of Post-Intensive Care Syndrome (PICS) monitoring. The effect of the package (nutritional recommendations + physiotherapy protocol vs. standard of care) will be evaluated.

Detailed Description
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Intensive medicine keeps pushing its borders, and enables survival of critical illnesses, including the substitution of organ functions in patients with multiple organ dysfunction (MODS). Despite the improvements in short-term outcomes, the long-term prognosis and quality of life (long-term outcomes) in patients, who survived a critical condition at ICU, remain unfavorable. The long-term consequences may persist for months or even years. Post-intensive care syndrome (PICS) represents a significantly limiting impairment in three areas: physical (polyneuromyopathy of critically-ill patients), cognitive (delirium), and mental (development of depressions and PTSD - post-traumatic stress disorder). It is especially the rapid deterioration of muscles caused with the catabolic effect of the illness itself during accentuated proteolysis, very negatively affects the muscle strength, inability to discontinue artificial ventilation in the patient, increase of infections, and prolongation of the ICU stay. It often results in the inability to discharge the patient into home care. Polyneuromyopathy affects up to 40% of critically-ill patients; at the greatest risk are especially patients in a serious catabolic state, with activated systemic inflammatory response, with microvascular ischemia, on corticosteroids, immobilized, and on long-term artificial ventilation. The prevention is difficult, as well as monitoring of the lean body mass (LBM), especially in the muscle mass of critically ill patients, who are further affected with changes in hydration and fluid leak. BIA - bioelectric impedance is a non-invasive technique, which is able, on the basis of impedance, to evaluate body composition (muscles, fat, total body fluid), determine hydration (ratio of extracellular and intracellular fluid, fluid retention); another prognostic marker is also the phase angle. It helps to evaluate markers of nutrition, basal energetic metabolism. The BIS Multiscan 5000 device measures 50 frequencies, which are used to create a Cole Plot, using a mathematical model. It enables obtaining data from bed-ridden critically-ill patients, using tetrapolar bioelectric impedance.

Official Title
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Bioelectric Impedance Analysis (BIA) Assessment of Polymyoneuropathy in Critically Ill Patients as a Part of Post-ICU Syndrome

Conditions
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Sepsis, Trauma, Respiratory Insufficiency, Surgery

Intervention / Treatment
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* Other: Nutritional and physiotherapy protocol, BIA
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with respiratory insufficiency Expected period of artificial ventilation of 7 days Acute lung injury (ALI) Acute respiratory distress syndrome (ARDS) Acute exacerbation of chronic obstructive pulmonary disease (COPD) Signed informed consent (may be signed by witnesses, if the patient is unconscious) Exclusion Criteria: Patients with unfavorable prognosis for 12-week follow-up APACHE Score >30 Metastasizing malignity Patients after cardiopulmonary resuscitation (CPR) prior to admission Cerebral edema Cerebral trauma Intracranial hypertension Liver cirrhosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are two arms in the study - experimental group (diagnostics with the Multiscan 5000 device, nutritional recommendations, physiotherapy protocol), and control group (standard of care)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional and physiotherapy protocol, BIA<br>Study subjects randomized into this study arm will be indicated for nutritional and physiotherapy protocol, based upon the obtained results of the measurements, using bioimpedance analysis. | Other: Nutritional and physiotherapy protocol, BIA<br>* Study subjects will be treated using the nutritional and physiotherapy protocol, based upon the results of measurements, using bioimpedance analysis.<br>|
| Active Comparator: Standard of care<br>Study subjects randomized into this study arm will be provided the current standard of care. | Other: Standard of care<br>* Study subjects will receive the current standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Body composition will be studied using bioimpedance analysis - comparison of skeletal muscle mass, fats, body fluids | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the albumin level | Changes in the albumin level will be observed (in grams/Litre) | 12 weeks | 
| Changes in the prealbumin level | Changes in the prealbumin level will be observed (in milligrams/Litre) | 12 weeks | 
| Changes in the C-reactive protein (CRP) level | Changes in the C-reactive protein (CRP) level will be observed (in milligrams/Litre) | 12 weeks | 
| Changes in the presepsin level | Changes in the presepsin level will be observed (in picograms/millilitre) | 12 weeks | 
| Comparison of muscle functions | Comparison of muscle functions will be performed using dynamometry. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polymyoneuropathy, bioelectric impedance, post-intensive care syndrome, multiple organ dysfunction