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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Respiratory Insufficiency; Trauma; Surgery
• Intervention / Treatment: Other: Nutritional and physiotherapy protocol, BIA; Other: Standard of care

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiří Hynčica; Phone Number: 2587 0042059737; Email: jiri.hyncica@fno.cz

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 70852
      • Recruiting
      • University Hospital Ostrava
      • Contact: Jiří Hynčica; Phone Number: 2587 0042059737; Email: jiri.hyncica@fno.cz
      • Principal Investigator: Marcela Káňová, MD,Ph.D.
      • Sub-Investigator: Vojtěch Vodička, MD
      • Sub-Investigator: Klára Rusková, Mgr.
      • Sub-Investigator: Ivana Nytra, Mgr.
      • Sub-Investigator: Martina Stodůlková, DiS.
      • Sub-Investigator: Ján Šida, Mgr.
    • Ostrava, Moravian-Silesian Region, Czechia, 70300
      • Recruiting
      • University of Ostrava, Department of Physiology and Patophysiology
      • Contact: Karin Petřeková, Mgr., Ph.D.; Phone Number: 1773 0042055346; Email: karin.petrekova@osu.cz
      • Principal Investigator: Karin Petřeková, Mgr., Ph.D.
      • Sub-Investigator: Iva Chwalková, Mgr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional and physiotherapy protocol, BIA; 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.	Other: Nutritional and physiotherapy protocol, BIA; Study subjects will be treated using the nutritional and physiotherapy protocol, based upon the results of measurements, using bioimpedance analysis.
Active Comparator: Standard of care; Study subjects randomized into this study arm will be provided the current standard of care.	Other: Standard of care; Study subjects will receive the current standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Body composition will be studied using bioimpedance analysis - comparison of skeletal muscle mass, fats, body fluids	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the albumin level	Changes in the albumin level will be observed (in grams/Litre)	12 weeks
Changes in the prealbumin level	Changes in the prealbumin level will be observed (in milligrams/Litre)	12 weeks
Changes in the C-reactive protein (CRP) level	Changes in the C-reactive protein (CRP) level will be observed (in milligrams/Litre)	12 weeks
Changes in the presepsin level	Changes in the presepsin level will be observed (in picograms/millilitre)	12 weeks
Comparison of muscle functions	Comparison of muscle functions will be performed using dynamometry.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional limitations - time up and go test (TUG)	Functional limitations will be assessed with TUG (time up and go test) (in seconds)	12 weeks
Functional limitations - spirometry - forced vital capacity (FCV)	Functional limitations will be assessed with spirometry - forced vital capacity (FCV) (volume)	12 weeks
Functional limitations - spirometry - forced expiratory velocity (FEV1)	Functional limitations will be assessed with spirometry - forced expiratory velocity in one second (FEV1) (velocity)	12 weeks
Cognitive state	Cognitive state of study subjects will be assessed with the presence of post-traumatic stress disorder (PTSD)	12 weeks

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Collaborators: University of Ostrava
• Investigators: Principal Investigator: Marcela Káňová, MD, Ph.D., University Hospital Ostrava

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: polymyoneuropathy; bioelectric impedance; post-intensive care syndrome; multiple organ dysfunction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: KARIM-BIA-Ka21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No