BIA Assessment of Polymyoneuropathy in Critically Ill Patients

NCT04758676 | Unknown

• 1 other identifier: KARIM-BIA-Ka21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Sepsis; Trauma; Respiratory Insufficiency; Surgery

Keywords

polymyoneuropathy; bioelectric impedance; post-intensive care syndrome; multiple organ dysfunction

Outcome Measures

Primary Outcomes (1)

• Body composition

  Body composition will be studied using bioimpedance analysis - comparison of skeletal muscle mass, fats, body fluids

  12 weeks

Secondary Outcomes (5)

• Changes in the albumin level

  12 weeks

• Changes in the prealbumin level

  12 weeks

• Changes in the C-reactive protein (CRP) level

  12 weeks

• Changes in the presepsin level

  12 weeks

• Comparison of muscle functions

  12 weeks

Other Outcomes (4)

• Functional limitations - time up and go test (TUG)

  12 weeks

• Functional limitations - spirometry - forced vital capacity (FCV)

  12 weeks

• Functional limitations - spirometry - forced expiratory velocity (FEV1)

  12 weeks

Study Arms (2)

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.

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.

Other: Standard of care

Interventions

Nutritional and physiotherapy protocol, BIA OTHER

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

Nutritional and physiotherapy protocol, BIA

Standard of care OTHER

Study subjects will receive the current standard of care.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead
• University of Ostrava: collaborator

Study Sites (2)

University of Ostrava, Department of Physiology and Patophysiology

Ostrava, Moravian-Silesian Region, 70300, Czechia

RECRUITING

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related Publications (1)

• 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.

  PMID: 41511101 DERIVED

MeSH Terms

Conditions

Sepsis; Wounds and Injuries; Respiratory Insufficiency; postintensive care syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marcela Káňová, MD, Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is used in the study
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: February 17, 2021
• Study Start: March 1, 2021
• Primary Completion: February 29, 2024
• Study Completion: May 31, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)