Clinical trial NCT04758676: BIA Assessment of Polymyoneuropathy in Critically Ill Patients
Official title: Bioelectric Impedance Analysis (BIA) Assessment of Polymyoneuropathy in Critically Ill Patients as a Part of Post-ICU Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Trauma
Respiratory Insufficiency
Surgery
Keywords: polymyoneuropathy
bioelectric impedance
post-intensive care syndrome
multiple organ dysfunction
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: University of Ostrava
First posted: 2021-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body composition
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in the albumin level
timeFrame: 12 weeks
measure: Changes in the prealbumin level
timeFrame: 12 weeks
measure: Changes in the C-reactive protein (CRP) level
timeFrame: 12 weeks
measure: Changes in the presepsin level
timeFrame: 12 weeks
measure: Comparison of muscle functions
timeFrame: 12 weeks
Other outcomes:
measure: Functional limitations - time up and go test (TUG)
timeFrame: 12 weeks
measure: Functional limitations - spirometry - forced vital capacity (FCV)
timeFrame: 12 weeks
measure: Functional limitations - spirometry - forced expiratory velocity (FEV1)
timeFrame: 12 weeks
measure: Cognitive state
timeFrame: 12 weeks
Locations:
city: Ostrava
country: Czechia
facility: University of Ostrava, Department of Physiology and Patophysiology
state: Moravian-Silesian Region
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Marcela Káňová, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: