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BIA Assessment of Polymyoneuropathy in Critically Ill Patients

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04758676
Enrollment
60
Registered
2021-02-17
Start date
2021-03-01
Completion date
2024-05-31
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Insufficiency, Sepsis, Surgery, Trauma

Keywords

polymyoneuropathy, bioelectric impedance, post-intensive care syndrome, multiple organ dysfunction

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.

Interventions

OTHERNutritional and physiotherapy protocol, BIA

Study subjects will be treated using the nutritional and physiotherapy protocol, based upon the results of measurements, using bioimpedance analysis.

OTHERStandard of care

Study subjects will receive the current standard of care.

Sponsors

University of Ostrava
CollaboratorOTHER
University Hospital Ostrava
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

No masking is used in the study

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Body composition12 weeksBody composition will be studied using bioimpedance analysis - comparison of skeletal muscle mass, fats, body fluids

Secondary

MeasureTime frameDescription
Changes in the prealbumin level12 weeksChanges in the prealbumin level will be observed (in milligrams/Litre)
Changes in the albumin level12 weeksChanges in the albumin level will be observed (in grams/Litre)
Changes in the C-reactive protein (CRP) level12 weeksChanges in the C-reactive protein (CRP) level will be observed (in milligrams/Litre)
Changes in the presepsin level12 weeksChanges in the presepsin level will be observed (in picograms/millilitre)
Comparison of muscle functions12 weeksComparison of muscle functions will be performed using dynamometry.

Other

MeasureTime frameDescription
Functional limitations - spirometry - forced expiratory velocity (FEV1)12 weeksFunctional limitations will be assessed with spirometry - forced expiratory velocity in one second (FEV1) (velocity)
Cognitive state12 weeksCognitive state of study subjects will be assessed with the presence of post-traumatic stress disorder (PTSD)
Functional limitations - spirometry - forced vital capacity (FCV)12 weeksFunctional limitations will be assessed with spirometry - forced vital capacity (FCV) (volume)
Functional limitations - time up and go test (TUG)12 weeksFunctional limitations will be assessed with TUG (time up and go test) (in seconds)

Countries

Czechia

Contacts

Primary ContactJiří Hynčica
jiri.hyncica@fno.cz0042059737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026