Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758676
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2021-01-14
Brief Title:
BIA Assessment of Polymyoneuropathy in Critically Ill Patients
Sponsor:
University Hospital Ostrava
Organization:
University Hospital Ostrava
Study Overview
Official Title:
Bioelectric Impedance Analysis BIA Assessment of Polymyoneuropathy in Critically Ill Patients as a Part of Post-ICU Syndrome
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None