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BIA Assessment of Polymyoneuropathy in Critically Ill Patients

Primary Purpose

Sepsis, Trauma, Respiratory Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Nutritional and physiotherapy protocol, BIA
Standard of care
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sepsis focused on measuring polymyoneuropathy, bioelectric impedance, post-intensive care syndrome, multiple organ dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Ostrava, Department of Physiology and PatophysiologyRecruiting
  • University Hospital OstravaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nutritional and physiotherapy protocol, BIA

Standard of care

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 14, 2021
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
Collaborators
University of Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT04758676
Brief Title
BIA Assessment of Polymyoneuropathy in Critically Ill Patients
Official Title
Bioelectric Impedance Analysis (BIA) Assessment of Polymyoneuropathy in Critically Ill Patients as a Part of Post-ICU Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
Collaborators
University of Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Trauma, Respiratory Insufficiency, Surgery
Keywords
polymyoneuropathy, bioelectric impedance, post-intensive care syndrome, multiple organ dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
None (Open Label)
Masking Description
No masking is used in the study
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutritional and physiotherapy protocol, BIA
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Study subjects randomized into this study arm will be provided the current standard of care.
Intervention Type
Other
Intervention Name(s)
Nutritional and physiotherapy protocol, BIA
Intervention Description
Study subjects will be treated using the nutritional and physiotherapy protocol, based upon the results of measurements, using bioimpedance analysis.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Study subjects will receive the current standard of care.
Primary Outcome Measure Information:
Title
Body composition
Description
Body composition will be studied using bioimpedance analysis - comparison of skeletal muscle mass, fats, body fluids
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in the albumin level
Description
Changes in the albumin level will be observed (in grams/Litre)
Time Frame
12 weeks
Title
Changes in the prealbumin level
Description
Changes in the prealbumin level will be observed (in milligrams/Litre)
Time Frame
12 weeks
Title
Changes in the C-reactive protein (CRP) level
Description
Changes in the C-reactive protein (CRP) level will be observed (in milligrams/Litre)
Time Frame
12 weeks
Title
Changes in the presepsin level
Description
Changes in the presepsin level will be observed (in picograms/millilitre)
Time Frame
12 weeks
Title
Comparison of muscle functions
Description
Comparison of muscle functions will be performed using dynamometry.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Functional limitations - time up and go test (TUG)
Description
Functional limitations will be assessed with TUG (time up and go test) (in seconds)
Time Frame
12 weeks
Title
Functional limitations - spirometry - forced vital capacity (FCV)
Description
Functional limitations will be assessed with spirometry - forced vital capacity (FCV) (volume)
Time Frame
12 weeks
Title
Functional limitations - spirometry - forced expiratory velocity (FEV1)
Description
Functional limitations will be assessed with spirometry - forced expiratory velocity in one second (FEV1) (velocity)
Time Frame
12 weeks
Title
Cognitive state
Description
Cognitive state of study subjects will be assessed with the presence of post-traumatic stress disorder (PTSD)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcela Káňová, MD, Ph.D.
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ostrava, Department of Physiology and Patophysiology
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70300
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Petřeková, Mgr., Ph.D.
Phone
0042055346
Ext
1773
Email
karin.petrekova@osu.cz
First Name & Middle Initial & Last Name & Degree
Karin Petřeková, Mgr., Ph.D.
First Name & Middle Initial & Last Name & Degree
Iva Chwalková, Mgr.
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Marcela Káňová, MD,Ph.D.
First Name & Middle Initial & Last Name & Degree
Vojtěch Vodička, MD
First Name & Middle Initial & Last Name & Degree
Klára Rusková, Mgr.
First Name & Middle Initial & Last Name & Degree
Ivana Nytra, Mgr.
First Name & Middle Initial & Last Name & Degree
Martina Stodůlková, DiS.
First Name & Middle Initial & Last Name & Degree
Ján Šida, Mgr.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.

Learn more about this trial

BIA Assessment of Polymyoneuropathy in Critically Ill Patients

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