An interventional study of Nutritional and physiotherapy protocol, BIA and Standard of care in Sepsis, Trauma and Respiratory Insufficiency, sponsored by University Hospital Ostrava. Recruiting at 2 sites in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Diagnostic
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.
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →University Hospital Ostrava is the lead sponsor of 146 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 randomized into this study arm will be provided the current standard of care.
Other: Standard of care
Study subjects will be treated using the nutritional and physiotherapy protocol, based upon the results of measurements, using bioimpedance analysis.
Study subjects will receive the current standard of care.
Body composition
Body composition will be studied using bioimpedance analysis - comparison of skeletal muscle mass, fats, body fluids
Time frame: 12 weeks
Changes in the albumin level
Changes in the albumin level will be observed (in grams/Litre)
Time frame: 12 weeks
Changes in the prealbumin level
Changes in the prealbumin level will be observed (in milligrams/Litre)
Time frame: 12 weeks
Changes in the C-reactive protein (CRP) level
Changes in the C-reactive protein (CRP) level will be observed (in milligrams/Litre)
Time frame: 12 weeks
Changes in the presepsin level
Changes in the presepsin level will be observed (in picograms/millilitre)
Time frame: 12 weeks
Comparison of muscle functions
Comparison of muscle functions will be performed using dynamometry.
Time frame: 12 weeks
Functional limitations - time up and go test (TUG)
Functional limitations will be assessed with TUG (time up and go test) (in seconds)
Time frame: 12 weeks
Functional limitations - spirometry - forced vital capacity (FCV)
Functional limitations will be assessed with spirometry - forced vital capacity (FCV) (volume)
Time frame: 12 weeks
Functional limitations - spirometry - forced expiratory velocity (FEV1)
Functional limitations will be assessed with spirometry - forced expiratory velocity in one second (FEV1) (velocity)
Time frame: 12 weeks
Cognitive state
Cognitive state of study subjects will be assessed with the presence of post-traumatic stress disorder (PTSD)
Time frame: 12 weeks
Plan to share: No — There is no plan to make individual participant data available to other researchers.
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University Hospital Ostrava