SepsisNCT04758676
BIA Assessment of Polymyoneuropathy in Critically Ill Patients
A study testing Nutritional and physiotherapy protocol, BIA in people with Sepsis and Trauma, run by University Hospital Ostrava at 2 sites in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Trauma, Respiratory Insufficiency
- What is being tested?
- Nutritional and physiotherapy protocol, BIA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Mar 2021to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
University of Ostrava, Department of Physiology and Patophysiology
Ostrava, Moravian-Silesian Region, 70300
Karin Petřeková, Mgr., Ph.D., 0042055346 ext. 1773, karin.petrekova@osu.cz
Karin Petřeková, Mgr., Ph.D.
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Marcela Káňová, MD,Ph.D.
About this study
Official title: Bioelectric Impedance Analysis (BIA) Assessment of Polymyoneuropathy in Critically Ill Patients as a Part of Post-ICU Syndrome
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.
Read the 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.
- Conditions
- Sepsis, Trauma, Respiratory Insufficiency, Surgery
- Being tested
- Nutritional and physiotherapy protocol, BIA, Standard of care
- Keywords
- polymyoneuropathy, bioelectric impedance, post-intensive care syndrome, multiple organ dysfunction
- Medical subject headings
- Sepsis, Wounds and Injuries, Respiratory Insufficiency, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional and physiotherapy protocol, BIAOther
Study subjects will be treated using the nutritional and physiotherapy protocol, based upon the results of measurements, using bioimpedance analysis.
Standard of careOther
Study subjects will receive the current standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional and physiotherapy protocol, BIA | 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. Receives: Other: Nutritional and physiotherapy protocol, BIA |
| Standard of care | Active comparator | Study subjects randomized into this study arm will be provided the current standard of care. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Body composition will be studied using bioimpedance analysis - comparison of skeletal muscle mass, fats, body fluids
Measured: 12 weeks
Secondary outcomes (5)
Changes in the albumin level
Changes in the albumin level will be observed (in grams/Litre)
Measured: 12 weeks
Changes in the prealbumin level
Changes in the prealbumin level will be observed (in milligrams/Litre)
Measured: 12 weeks
Changes in the C-reactive protein (CRP) level
Changes in the C-reactive protein (CRP) level will be observed (in milligrams/Litre)
Measured: 12 weeks
Changes in the presepsin level
Changes in the presepsin level will be observed (in picograms/millilitre)
Measured: 12 weeks
Comparison of muscle functions
Comparison of muscle functions will be performed using dynamometry.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Mar 2021
- Primary completion29 Feb 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ostrava
- Responsible party
- Sponsor
- Investigators
- Marcela Káňová, MD, Ph.D., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758676
- Sponsor's protocol ID
- KARIM-BIA-Ka21
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Kanova M, Petrekova K, Borzenko N, Ruskova K, Nytra I, Dzurnakova P, Burda M, Konvicka J. Bioelectrical Impedance in Monitoring Hyperhydration and Muscle Wasting in Critically Ill Corona Virus Disease (COVID-19) Patients: The Feasibility of Predicting Outcome. Physiol Res. 2025 Dec 31;74(Suppl 1):S93-S106. doi: 10.33549/physiolres.935748.
PubMed 41511101
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioelectric Impedance Analysis (BIA) Assessment of Polymyoneuropathy in Critically Ill Patients as a Part of Post-ICU Syndrome
- ClinicalTrials.gov ID
- NCT04758676
- Acronym / sponsor ID
- KARIM-BIA-Ka21
- Conditions
- Sepsis, Trauma, Respiratory Insufficiency, Surgery
- Keywords
- polymyoneuropathy, bioelectric impedance, post-intensive care syndrome, multiple organ dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- University of Ostrava
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Nutritional and physiotherapy protocol, BIA | Experimental | Other: Nutritional and physiotherapy protocol, BIAStudy 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. |
| Standard of care | Active comparator | Other: Standard of careStudy subjects randomized into this study arm will be provided the current standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- Patients with unfavorable prognosis for 12-week follow-up
- APACHE Score >30
- Metastasizing malignity
- Patients after cardiopulmonary resuscitation (CPR) prior to admission
- Cerebral edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional and physiotherapy protocol, BIAStudy subjects will be treated using the nutritional and physiotherapy protocol, based upon the results of measurements, using bioimpedance analysis. | Other | Nutritional and physiotherapy protocol, BIA |
| Standard of careStudy subjects will receive the current standard of care. | Other | Standard of care |
Primary outcome
Body composition
Time frame: 12 weeks
Body composition will be studied using bioimpedance analysis - comparison of skeletal muscle mass, fats, body fluids
5 secondary outcomes
Changes in the albumin level
Time frame: 12 weeks
Changes in the prealbumin level
Time frame: 12 weeks
Changes in the C-reactive protein (CRP) level
Time frame: 12 weeks
Changes in the presepsin level
Time frame: 12 weeks
Comparison of muscle functions
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 41511101Kanova M, Petrekova K, Borzenko N, Ruskova K, Nytra I, Dzurnakova P, Burda M, Konvicka J. Bioelectrical Impedance in Monitoring Hyperhydration and Muscle Wasting in Critically Ill Corona Virus Disease (COVID-19) Patients: The Feasibility of Predicting Outcome. Physiol Res. 2025 Dec 31;74(Suppl 1):S93-S106. doi: 10.33549/physiolres.935748.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcela Káňová, MD, Ph.D. principal investigator
University Hospital Ostrava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional and physiotherapy protocol, BIA in people with Sepsis and Trauma, run by University Hospital Ostrava at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04758676, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.