BIA Assessment of Polymyoneuropathy in Critically Ill Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nutritional and physiotherapy protocol, BIA 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
Study subjects will be treated using the nutritional and physiotherapy protocol, based upon the results of measurements, using bioimpedance analysis.
|
| Active Comparator: Standard of care Study subjects randomized into this study arm will be provided the current standard of care. |
Other: Standard of care
Study subjects will receive the current standard of care.
|
Outcome Measures
Primary Outcome Measures
- Body composition [12 weeks]
Body composition will be studied using bioimpedance analysis - comparison of skeletal muscle mass, fats, body fluids
Secondary Outcome Measures
- Changes in the albumin level [12 weeks]
Changes in the albumin level will be observed (in grams/Litre)
- Changes in the prealbumin level [12 weeks]
Changes in the prealbumin level will be observed (in milligrams/Litre)
- Changes in the C-reactive protein (CRP) level [12 weeks]
Changes in the C-reactive protein (CRP) level will be observed (in milligrams/Litre)
- Changes in the presepsin level [12 weeks]
Changes in the presepsin level will be observed (in picograms/millilitre)
- Comparison of muscle functions [12 weeks]
Comparison of muscle functions will be performed using dynamometry.
Other Outcome Measures
- Functional limitations - time up and go test (TUG) [12 weeks]
Functional limitations will be assessed with TUG (time up and go test) (in seconds)
- Functional limitations - spirometry - forced vital capacity (FCV) [12 weeks]
Functional limitations will be assessed with spirometry - forced vital capacity (FCV) (volume)
- Functional limitations - spirometry - forced expiratory velocity (FEV1) [12 weeks]
Functional limitations will be assessed with spirometry - forced expiratory velocity in one second (FEV1) (velocity)
- Cognitive state [12 weeks]
Cognitive state of study subjects will be assessed with the presence of post-traumatic stress disorder (PTSD)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with respiratory insufficiency
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Expected period of artificial ventilation of 7 days
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Acute lung injury (ALI)
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Acute respiratory distress syndrome (ARDS)
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Acute exacerbation of chronic obstructive pulmonary disease (COPD)
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Signed informed consent (may be signed by witnesses, if the patient is unconscious)
Exclusion Criteria:
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Patients with unfavorable prognosis for 12-week follow-up
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APACHE Score >30
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Metastasizing malignity
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Patients after cardiopulmonary resuscitation (CPR) prior to admission
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Cerebral edema
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Cerebral trauma
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Intracranial hypertension
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Liver cirrhosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Ostrava, Department of Physiology and Patophysiology | Ostrava | Moravian-Silesian Region | Czechia | 70300 |
| 2 | University Hospital Ostrava | Ostrava | Moravian-Silesian Region | Czechia | 70852 |
Sponsors and Collaborators
- University Hospital Ostrava
- University of Ostrava
Investigators
- Principal Investigator: Marcela Káňová, MD, Ph.D., University Hospital Ostrava
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KARIM-BIA-Ka21