BIA Assessment of Polymyoneuropathy in Critically Ill Patients

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758676
• Other study ID #: KARIM-BIA-Ka21
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: University Hospital Ostrava
• Contact: Jirí Hyncica
• Phone: 0042059737
• Email: jiri.hyncica[@]fno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Insufficiency
• Sepsis
• Surgery
• Trauma

Intervention

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.
• Standard of care
Study subjects will receive the current standard of care.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region
Czechia	University of Ostrava, Department of Physiology and Patophysiology	Ostrava	Moravian-Silesian Region

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Ostrava	University of Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional limitations - time up and go test (TUG)	Functional limitations will be assessed with TUG (time up and go test) (in seconds)	12 weeks
Other	Functional limitations - spirometry - forced vital capacity (FCV)	Functional limitations will be assessed with spirometry - forced vital capacity (FCV) (volume)	12 weeks
Other	Functional limitations - spirometry - forced expiratory velocity (FEV1)	Functional limitations will be assessed with spirometry - forced expiratory velocity in one second (FEV1) (velocity)	12 weeks
Other	Cognitive state	Cognitive state of study subjects will be assessed with the presence of post-traumatic stress disorder (PTSD)	12 weeks
Primary	Body composition	Body composition will be studied using bioimpedance analysis - comparison of skeletal muscle mass, fats, body fluids	12 weeks
Secondary	Changes in the albumin level	Changes in the albumin level will be observed (in grams/Litre)	12 weeks
Secondary	Changes in the prealbumin level	Changes in the prealbumin level will be observed (in milligrams/Litre)	12 weeks
Secondary	Changes in the C-reactive protein (CRP) level	Changes in the C-reactive protein (CRP) level will be observed (in milligrams/Litre)	12 weeks
Secondary	Changes in the presepsin level	Changes in the presepsin level will be observed (in picograms/millilitre)	12 weeks
Secondary	Comparison of muscle functions	Comparison of muscle functions will be performed using dynamometry.	12 weeks