NCT04758676|Unknown
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
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Bioelectric Impedance Analysis (BIA) Assessment of Polymyoneuropathy in Critically Ill Patients as a Part of Post-ICU Syndrome
Sponsor study identifier
interventional
60
1 country
2
Study Start
March 1, 2021
Actual (reported)Primary Completion
February 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 14, 2021
Actual (reported)February 17, 2021
Actual (reported)March 1, 2021
Actual (reported)February 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Body composition
Body composition will be studied using bioimpedance analysis - comparison of skeletal muscle mass, fats, body fluids
12 weeks
Changes in the albumin level
12 weeks
Changes in the prealbumin level
12 weeks
Changes in the C-reactive protein (CRP) level
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.
Study subjects randomized into this study arm will be provided the current standard of care.
Study subjects will be treated using the nutritional and physiotherapy protocol, based upon the results of measurements, using bioimpedance analysis.
Study subjects will receive the current standard of care.
University of Ostrava, Department of Physiology and Patophysiology
Ostrava, Moravian-Silesian Region, 70300, Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852, Czechia
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.
Marcela Káňová, MD, Ph.D.
University Hospital Ostrava
First Submitted
January 14, 2021
First Posted
February 17, 2021
Study Start
March 1, 2021
Actual (reported)A Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis)
12 weeks
Changes in the presepsin level
12 weeks
Comparison of muscle functions
12 weeks
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 18, 2024
Record last verified: 2024-01
There is no plan to make individual participant data available to other researchers.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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