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

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What is being tested

Nutritional and physiotherapy protocol, BIA

+ Standard of care

Other
Who is being recruted

Infections+7

+ Inflammation

+ Pathologic Processes

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: March 2021
See protocol details

Summary

Principal SponsorUniversity Hospital Ostrava
Study ContactJiří Hynčica
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2021

Actual date on which the first participant was enrolled.

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.

Official TitleBioelectric Impedance Analysis (BIA) Assessment of Polymyoneuropathy in Critically Ill Patients as a Part of Post-ICU Syndrome
NCT04758676
Principal SponsorUniversity Hospital Ostrava
Study ContactJiří Hynčica
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsInflammationPathologic ProcessesRespiration DisordersRespiratory InsufficiencyRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsWounds and InjuriesSystemic Inflammatory Response SyndromeSepsis

Criteria

6 inclusion criteria required to participate
Patients with respiratory insufficiency

Expected period of artificial ventilation of 7 days

Acute lung injury (ALI)

Acute respiratory distress syndrome (ARDS)

Show More Criteria

8 exclusion criteria prevent from participating
Patients with unfavorable prognosis for 12-week follow-up

APACHE Score >30

Metastasizing malignity

Patients after cardiopulmonary resuscitation (CPR) prior to admission

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Active Comparator
Study subjects randomized into this study arm will be provided the current standard of care.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

University of Ostrava, Department of Physiology and Patophysiology

Ostrava, CzechiaOpen University of Ostrava, Department of Physiology and Patophysiology in Google Maps
Recruiting

University Hospital Ostrava

Ostrava, Czechia
Recruiting
2 Study Centers