BIA Assessment of Polymyoneuropathy in Critically Ill Patients

NCT ID: NCT04758676

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2024-05-31

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.

Conditions

Sepsis; Trauma; Respiratory Insufficiency; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nutritional and physiotherapy protocol, BIA

Intervention Type: OTHER

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

Standard of care

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

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

Study subjects will receive the current standard of care.

Interventions

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.

Intervention Type: OTHER

Standard of care

Study subjects will receive the current standard of care.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ostrava

OTHER

Sponsor Role: collaborator

University Hospital Ostrava

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcela Káňová, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

University of Ostrava, Department of Physiology and Patophysiology

Ostrava, Moravian-Silesian Region, Czechia

Site Status: RECRUITING

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jiří Hynčica

Role: CONTACT

jiri.hyncica@fno.cz

0042059737 ext. 2587

Facility Contacts

Karin Petřeková, Mgr., Ph.D.

Role: primary

karin.petrekova@osu.cz

0042055346 ext. 1773

Jiří Hynčica

Role: primary

jiri.hyncica@fno.cz

0042059737 ext. 2587

Other Identifiers

KARIM-BIA-Ka21

Identifier Type: -

Identifier Source: org_study_id