xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05991778</url>
    </required_header>
    <id_info>
      <org_study_id>KARIM-2022-BIVA</org_study_id>
      <secondary_id>SGS09/LF/2022</secondary_id>
      <nct_id>NCT05991778</nct_id>
    </id_info>
    <brief_title>Bioelectrical Impedance in Monitoring Hyperhydration and Polyneuromyopathy in Critically Ill Patients</brief_title>
    <official_title>Bioelectrical Impedance Vector Analysis (BIVA) in Monitoring Hyperhydration and Polyneuromyopathy in Critically Ill Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Ostrava</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital Ostrava</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This prospective, blinded observational clinical study was aimed to determine the effect of&#xD;
        hyperhydration and muscle loss measured by Bioelectrical impedance vector analysis (BIVA) on&#xD;
        mortality. The aim was to compare hydratation parameters measured by BIVA: OHY, Extracellular&#xD;
        Water (ECW) / Total Body Wate (TBW) and quadrant, vector length, phase angle (PA) with&#xD;
        cumulative fluid balance (CFB) recording (input-output) in their ability in predicting&#xD;
        mortality as the abilities of the prognostic markers PA (BIVA), Acute Physiology and Chronic&#xD;
        Health Evaluation II (APACHE II - score) and presepsin (serum Cluster of Differentiation (CD)&#xD;
        14-ST). The investigators also compared BIVA nutritional indicators (SMM, fat) with BMI and&#xD;
        laboratory parameters (albumin, prealbumin and C-reactive protein (CRP) inflammation&#xD;
        parameters) in the prediction of mortality. An important goal was to evaluate the usability&#xD;
        of the BIVA method in critically ill patients on extracorporeal circulation, to compare the&#xD;
        impedance data of the extracorporeal membrane oxygenation (ECMO) and non-ECMO groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hyperhydration has a detrimental effect on mortality risk and morbidity, increases the risk&#xD;
        of acute kidney failure, the need of renal replacement therapy (RRT), worsens recovery of&#xD;
        renal functions and worsens lung injury (ALI), infectious complications, and causes prolonged&#xD;
        artificial pulmonary ventilation (APV), the length of stay on Intensive care unit (ICU), and&#xD;
        impairs wound healing.&#xD;
  &#xD;
        Real-time assessment of fluid status and management of fluid administration in critically ill&#xD;
        patients is challenging. Echocardiography can rapidly identify hemodynamic phenotypes, but it&#xD;
        is rather intermittent than continuous methods and requires experienced and trained staff.&#xD;
        Semi-invasive methods, based on stroke volume monitoring as the area under the arterial curve&#xD;
        and variability of stroke volume variation (SVV) evaluate intravascular volume. However,&#xD;
        these methods lack information about the interstitial fluid, part of extracellular water&#xD;
        (ECW), or intracellular fluid water (ICW). This problem is partially solved by transpulmonary&#xD;
        thermodilution with extravascular lung water (EVLW) measurement and lung ultrasound.&#xD;
        Calculating the cumulative balance (CBF) is imprecise, especially in the area of fluid output&#xD;
        for insensible losses or third-space fluid losses. Even more imprecise is the clinical&#xD;
        assessment of peripheral edema and blood flow. And gold standard deuterium dilution methods&#xD;
        for total body water (TBW) are not usable in daily practice in the ICU settings.&#xD;
  &#xD;
        In addition to hyperhydration, the rapid loss of muscle tissue in critically ill patients has&#xD;
        a negative impact on the course of the disease. Polyneuromyopathy affects up to 40 % of&#xD;
        critically ill patients, patients in a severe catabolic state with an activated systemic&#xD;
        inflammatory response (SIRS), with corticosteroid therapy, and immobilized on long-term&#xD;
        artificial lung ventilation are at risk. Monitoring lean body mass, especially skeletal&#xD;
        muscle mass (SMM), is still difficult. Anthropometric measurements and ultrasound&#xD;
        measurements of the quadriceps muscles are not ideal because they are time-consuming and&#xD;
        require well-trained staff. Some laboratory parameters such as albumin are likely to be&#xD;
        influenced by inflammation (CRP), and hydration. Dual-energy X-ray absorptiometers (DEXA)&#xD;
        using two different wavelengths of low-intensity X-rays give a relatively accurate picture of&#xD;
        bone mass and soft tissues (fat-free mass, active mass, fat). However, repeated X-ray&#xD;
        examination in immobilized critically ill patients is not the method of choice.&#xD;
  &#xD;
        Bioelectrical impedance vector analysis (BIVA) is a simple, rapid, and noninvasive bedside&#xD;
        technique, based on the principle that the flow of altering electrical current through a&#xD;
        particular tissue differs depending on the content of water and electrolytes. It is thus able&#xD;
        to measure body composition as skeletal muscle mass (SMM), and body cell mass (BCM),&#xD;
        including total body water and extracellular water. And with the use of 50 frequencies of&#xD;
        bioimpedance spectroscopy (BIS), it is possible to distinguish TBW, ECW, and from their&#xD;
        different intracellular water, because only electric current with a frequency higher than 100&#xD;
        Hertz (Hz) passes through the cell membrane. However, the technique cannot distinguish&#xD;
        between intravascular and interstitial volumes in the extracellular compartment. According to&#xD;
        a number of studies, the results of bioimpedance parameters of body composition are&#xD;
        comparable to DEXA. However, BIA overestimates the representation of muscle. An important&#xD;
        parameter is the phase angle (PA), which detects a time delay of the passage of current&#xD;
        through the cell membrane, i.e., a phase shift between the sinusoidal voltage and current&#xD;
        waveforms. PA reflects BCM and serves as an important prognostic factor, with a normal value&#xD;
        of 4-15°.&#xD;
  &#xD;
        Of the laboratory markers, presepsin (PSEP) has prognostic significance. Presepsin, soluble&#xD;
        Cluster of differentiation 14 (sCD14), is a glycoprotein expressed in the membranes of&#xD;
        monocytes and macrophages in response to pathogen-associated molecular patterns (PAMPs:&#xD;
        lipopolysaccharide, peptidoglycan) part of the bacterial wall or to other damage to cells -&#xD;
        damage-associated molecular patterns (DAMPs). An interesting finding is its prognostic role,&#xD;
        i.e. higher values in non-surviving patients, evaluated by a number of studies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2021</start_date>
    <completion_date type="Actual">May 31, 2022</completion_date>
    <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Body Mass (physique) - Bioelectrical impedance analysis (BIA)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Bioelectrical impedance analysis (BIA) comparison of skeletal muscle mass, body fat and body water (expressed in %) in patients hospitalized in the ICU.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Mass (physique) - Phase Angle (PA)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Assessment of the Phase angle (expressed in degrees) as a part of BIA in patients hospitalized in the ICU.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Mass (physique) - BIVA vector analysis (Cole Cole graf)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Assessment of the BIVA vector analysis (Cole Cole graf, expressed as a optimal curve dependence of resistance on reactance always at a specific frequency, divided into quadrants) in patients hospitalized in the ICU.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Indicators of nutritional status (albumin, prealbumin)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Assesment of indicators of nutritional status (albumin, prealbumin in g/l) in serum of patients admitted to Intensive Care Unit (ICU).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Indicator of inflammation (CRP)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Assesment of indicator of inflammation (C-reactive protein in mg/L) in serum of patients admitted to Intensive Care Unit (ICU).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Indicator of inflammation - presepsin (PSEP)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Assesment of indicator of inflammation measurements (presepsin in ng/L) in serum of patients admitted to Intensive Care Unit (ICU).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Total body water (TBW)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Total body water measurements (in %) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Extracellular water (ECW)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Extracellular water measurements (in %) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Intracellular water (ICW)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Intracellular water measurements (in %) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Overhydration (OHY)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Overhydration measurements (in %) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Ratio ECW/TBW</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Ratio ECW/TBW measurements (in %) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Active body mass index (ATH)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Active body mass index measurements (in kg/m2) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Body mass index (BMI)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Body mass index measurements (in kg/m2) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Body fat mass index (BFMI)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Body fat mass index measurements (in kg/m2) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Fat-free mass index (FFMI)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Fat-free mass index measurements (in kg/m2) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Skeletal muscle mass (SMM)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Skeletal muscle mass measurements (in kg) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Body cell mass (BCM)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Body cell mass measurements (in kg) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Basal metabolic rate (BMR)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Basal metabolic rate measurements (in kcal) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Nutric index (NI)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Nutric index measurements (in %) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Prediction marker (PM)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Prediction marker measurements in patients admitted to Intensive Care Unit (ICU). The mark value under 0,75 indicates normal condition, value over 0,86 means critical condition.</description>
    </other_outcome>
    <other_outcome>
      <measure>Indicators of nutritional status (creatinine)</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Indicators of nutritional status measurements (creatinine in µmol/L) in serum of patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Level of 25-hydroxyvitamin D</measure>
      <time_frame>The first within 48 hours of admission, the second one week after admission and third before transport from the ICU</time_frame>
      <description>Level of 25-hydroxyvitamin D measurements (in nmol/L) in serum of patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Cumulative fluid balance (CFB)</measure>
      <time_frame>Every 24 hours until patient´s transport from the ICU</time_frame>
      <description>Cumulative fluid balance daily measurements (in ml) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Measurement of energy income</measure>
      <time_frame>Every 24 hours until patient´s transport from the ICU</time_frame>
      <description>Measurement of daily energy income (in kcals) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Measurement of protein income</measure>
      <time_frame>Every 24 hours until patient´s transport from the ICU</time_frame>
      <description>Measurement of daily protein income (in g) in patients admitted to Intensive Care Unit (ICU).</description>
    </other_outcome>
    <other_outcome>
      <measure>Assessment of the presence of delirium (CAM-ICU test)</measure>
      <time_frame>Every 24 hours until patient´s transport from the ICU</time_frame>
      <description>The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a simple and short test that enables continuous monitoring of the patients in conditions of ICU (measured as positive/negative).</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">61</enrollment>
    <condition>Respiratory Distress Syndrome, Acute</condition>
    <condition>Respiratory Insufficiency</condition>
    <condition>Lung Ventilator</condition>
    <condition>Hyperhydration</condition>
    <condition>Hypoxemia</condition>
    <condition>Chronic Obstructive Pulmonary Disease Exacerbation</condition>
    <condition>Septic Shock</condition>
    <arm_group>
      <arm_group_label>Group of Patients who Survived (S)</arm_group_label>
      <description>The group is defined by the number of patients who survived.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group of Patients who Died (D)</arm_group_label>
      <description>The group is defined by the number of patients who died.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Bioelectrical impedance vector analysis (BIVA)</intervention_name>
      <description>BIVA is a simple, rapid, and noninvasive method, based on the principle that the flow of altering electrical current through a particular tissue differs depending on the content of water and electrolytes, used for monitoring hydratation and nutritional status in critically ill patients.</description>
      <arm_group_label>Group of Patients who Died (D)</arm_group_label>
      <arm_group_label>Group of Patients who Survived (S)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Blood and urine analysis</intervention_name>
      <description>For regular measurement in 2-3 terms, depending on the length of hospitalization (the first measurement took place within 48 hours of admission, followed one week after admission and the last before transport from the ICU): laboratory indicators of nutritional status will also be taken (albumin, prealbumin, creatinine), inflammation (C-reactive protein, presepsin) and 25-hydroxyvitamin D level.</description>
      <arm_group_label>Group of Patients who Died (D)</arm_group_label>
      <arm_group_label>Group of Patients who Survived (S)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>cumulative water balance</intervention_name>
      <description>Cumulative balance is the sum of daily fluid balances during hospitalization.</description>
      <arm_group_label>Group of Patients who Died (D)</arm_group_label>
      <arm_group_label>Group of Patients who Survived (S)</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Full blood and urine&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Critically ill adult patients admitted to 24 beds ICU of the University Hospital with the&#xD;
          development of ARDS and the assumption of at least 7 days of artificial lung ventilation&#xD;
          (medical, trauma, surgical patients) at the time of admission to the ICU.&#xD;
  &#xD;
          Informed consent was obtained from the person legally responsible for the patient.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with respiratory insufficiency, with the assumption of at least 7 days of&#xD;
               artificial lung ventilation (medical, trauma, surgical patients)&#xD;
  &#xD;
            -  Primary acute respiratory distress syndrome (ARDS) (pulmonary involvement): pneumonia,&#xD;
               inhalation trauma, chest trauma (lung contusion), aspiration&#xD;
  &#xD;
            -  Secondary ARDS (extrapulmonary): sepsis, shock states, acute pancreatitis, polytrauma,&#xD;
               burns, non-cardiogenic shock, intoxication, TRALI (massive blood transfusion),&#xD;
               drowning&#xD;
  &#xD;
            -  Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with unfavorable prognosis&#xD;
  &#xD;
            -  APACHE II ≥30&#xD;
  &#xD;
            -  Metastatic malignancy&#xD;
  &#xD;
            -  Conditions after cardiopulmonary resuscitation (KPCR) before admission&#xD;
  &#xD;
            -  Cerebral edema&#xD;
  &#xD;
            -  Brain trauma&#xD;
  &#xD;
            -  Intracranial hypertension&#xD;
  &#xD;
            -  Liver cirrhosis&#xD;
  &#xD;
            -  A pre-existing neurodegenerative disease&#xD;
  &#xD;
            -  Patients with pacemakers, defibrillators, pregnancy (conditions contraindications to&#xD;
               use of bio-electrical impedance).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marcela Káňová, MD, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital Ostrava</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University Hospital Ostrava</name>
        <address>
          <city>Ostrava</city>
          <state>Czech Republic</state>
          <zip>70852</zip>
          <country>Czechia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
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      <PMID>22610181</PMID>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Bioelectrical impedance</keyword>
    <keyword>Hyperhydration</keyword>
    <keyword>Critical care</keyword>
    <keyword>Extracorporeal membrane oxygenation Mortality</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
      <mesh_term>Respiratory Distress Syndrome</mesh_term>
      <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
      <mesh_term>Respiratory Insufficiency</mesh_term>
      <mesh_term>Water Intoxication</mesh_term>
      <mesh_term>Hypoxia</mesh_term>
      <mesh_term>Disease Progression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no plan to share individual participant data with other researchers.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05991778
  org study id: KARIM-2022-BIVA
  secondary id: SGS09/LF/2022
  nct id: NCT05991778
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This prospective, blinded observational clinical study was aimed to determine the effect of
        hyperhydration and muscle loss measured by Bioelectrical impedance vector analysis (BIVA) on
        mortality. The aim was to compare hydratation parameters measured by BIVA: OHY, Extracellular
        Water (ECW) / Total Body Wate (TBW) and quadrant, vector length, phase angle (PA) with
        cumulative fluid balance (CFB) recording (input-output) in their ability in predicting
        mortality as the abilities of the prognostic markers PA (BIVA), Acute Physiology and Chronic
        Health Evaluation II (APACHE II - score) and presepsin (serum Cluster of Differentiation (CD)
        14-ST). The investigators also compared BIVA nutritional indicators (SMM, fat) with BMI and
        laboratory parameters (albumin, prealbumin and C-reactive protein (CRP) inflammation
        parameters) in the prediction of mortality. An important goal was to evaluate the usability
        of the BIVA method in critically ill patients on extracorporeal circulation, to compare the
        impedance data of the extracorporeal membrane oxygenation (ECMO) and non-ECMO groups.
  Hyperhydration has a detrimental effect on mortality risk and morbidity, increases the risk
        of acute kidney failure, the need of renal replacement therapy (RRT), worsens recovery of
        renal functions and worsens lung injury (ALI), infectious complications, and causes prolonged
        artificial pulmonary ventilation (APV), the length of stay on Intensive care unit (ICU), and
        impairs wound healing.
  
        Real-time assessment of fluid status and management of fluid administration in critically ill
        patients is challenging. Echocardiography can rapidly identify hemodynamic phenotypes, but it
        is rather intermittent than continuous methods and requires experienced and trained staff.
        Semi-invasive methods, based on stroke volume monitoring as the area under the arterial curve
        and variability of stroke volume variation (SVV) evaluate intravascular volume. However,
        these methods lack information about the interstitial fluid, part of extracellular water
        (ECW), or intracellular fluid water (ICW). This problem is partially solved by transpulmonary
        thermodilution with extravascular lung water (EVLW) measurement and lung ultrasound.
        Calculating the cumulative balance (CBF) is imprecise, especially in the area of fluid output
        for insensible losses or third-space fluid losses. Even more imprecise is the clinical
        assessment of peripheral edema and blood flow. And gold standard deuterium dilution methods
        for total body water (TBW) are not usable in daily practice in the ICU settings.
  
        In addition to hyperhydration, the rapid loss of muscle tissue in critically ill patients has
        a negative impact on the course of the disease. Polyneuromyopathy affects up to 40 % of
        critically ill patients, patients in a severe catabolic state with an activated systemic
        inflammatory response (SIRS), with corticosteroid therapy, and immobilized on long-term
        artificial lung ventilation are at risk. Monitoring lean body mass, especially skeletal
        muscle mass (SMM), is still difficult. Anthropometric measurements and ultrasound
        measurements of the quadriceps muscles are not ideal because they are time-consuming and
        require well-trained staff. Some laboratory parameters such as albumin are likely to be
        influenced by inflammation (CRP), and hydration. Dual-energy X-ray absorptiometers (DEXA)
        using two different wavelengths of low-intensity X-rays give a relatively accurate picture of
        bone mass and soft tissues (fat-free mass, active mass, fat). However, repeated X-ray
        examination in immobilized critically ill patients is not the method of choice.
  
        Bioelectrical impedance vector analysis (BIVA) is a simple, rapid, and noninvasive bedside
        technique, based on the principle that the flow of altering electrical current through a
        particular tissue differs depending on the content of water and electrolytes. It is thus able
        to measure body composition as skeletal muscle mass (SMM), and body cell mass (BCM),
        including total body water and extracellular water. And with the use of 50 frequencies of
        bioimpedance spectroscopy (BIS), it is possible to distinguish TBW, ECW, and from their
        different intracellular water, because only electric current with a frequency higher than 100
        Hertz (Hz) passes through the cell membrane. However, the technique cannot distinguish
        between intravascular and interstitial volumes in the extracellular compartment. According to
        a number of studies, the results of bioimpedance parameters of body composition are
        comparable to DEXA. However, BIA overestimates the representation of muscle. An important
        parameter is the phase angle (PA), which detects a time delay of the passage of current
        through the cell membrane, i.e., a phase shift between the sinusoidal voltage and current
        waveforms. PA reflects BCM and serves as an important prognostic factor, with a normal value
        of 4-15°.
  
        Of the laboratory markers, presepsin (PSEP) has prognostic significance. Presepsin, soluble
        Cluster of differentiation 14 (sCD14), is a glycoprotein expressed in the membranes of
        monocytes and macrophages in response to pathogen-associated molecular patterns (PAMPs:
        lipopolysaccharide, peptidoglycan) part of the bacterial wall or to other damage to cells -
        damage-associated molecular patterns (DAMPs). An interesting finding is its prognostic role,
        i.e. higher values in non-surviving patients, evaluated by a number of studies.
  observational model: Cohort
  time perspective: Prospective
  measure: Body Mass (physique) - Bioelectrical impedance analysis (BIA)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Bioelectrical impedance analysis (BIA) comparison of skeletal muscle mass, body fat and body water (expressed in %) in patients hospitalized in the ICU.
  measure: Body Mass (physique) - Phase Angle (PA)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Assessment of the Phase angle (expressed in degrees) as a part of BIA in patients hospitalized in the ICU.
  measure: Body Mass (physique) - BIVA vector analysis (Cole Cole graf)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Assessment of the BIVA vector analysis (Cole Cole graf, expressed as a optimal curve dependence of resistance on reactance always at a specific frequency, divided into quadrants) in patients hospitalized in the ICU.
  measure: Indicators of nutritional status (albumin, prealbumin)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Assesment of indicators of nutritional status (albumin, prealbumin in g/l) in serum of patients admitted to Intensive Care Unit (ICU).
  measure: Indicator of inflammation (CRP)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Assesment of indicator of inflammation (C-reactive protein in mg/L) in serum of patients admitted to Intensive Care Unit (ICU).
  measure: Indicator of inflammation - presepsin (PSEP)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Assesment of indicator of inflammation measurements (presepsin in ng/L) in serum of patients admitted to Intensive Care Unit (ICU).
  measure: Total body water (TBW)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Total body water measurements (in %) in patients admitted to Intensive Care Unit (ICU).
  measure: Extracellular water (ECW)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Extracellular water measurements (in %) in patients admitted to Intensive Care Unit (ICU).
  measure: Intracellular water (ICW)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Intracellular water measurements (in %) in patients admitted to Intensive Care Unit (ICU).
  measure: Overhydration (OHY)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Overhydration measurements (in %) in patients admitted to Intensive Care Unit (ICU).
  measure: Ratio ECW/TBW
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Ratio ECW/TBW measurements (in %) in patients admitted to Intensive Care Unit (ICU).
  measure: Active body mass index (ATH)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Active body mass index measurements (in kg/m2) in patients admitted to Intensive Care Unit (ICU).
  measure: Body mass index (BMI)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Body mass index measurements (in kg/m2) in patients admitted to Intensive Care Unit (ICU).
  measure: Body fat mass index (BFMI)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Body fat mass index measurements (in kg/m2) in patients admitted to Intensive Care Unit (ICU).
  measure: Fat-free mass index (FFMI)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Fat-free mass index measurements (in kg/m2) in patients admitted to Intensive Care Unit (ICU).
  measure: Skeletal muscle mass (SMM)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Skeletal muscle mass measurements (in kg) in patients admitted to Intensive Care Unit (ICU).
  measure: Body cell mass (BCM)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Body cell mass measurements (in kg) in patients admitted to Intensive Care Unit (ICU).
  measure: Basal metabolic rate (BMR)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Basal metabolic rate measurements (in kcal) in patients admitted to Intensive Care Unit (ICU).
  measure: Nutric index (NI)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Nutric index measurements (in %) in patients admitted to Intensive Care Unit (ICU).
  measure: Prediction marker (PM)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Prediction marker measurements in patients admitted to Intensive Care Unit (ICU). The mark value under 0,75 indicates normal condition, value over 0,86 means critical condition.
  measure: Indicators of nutritional status (creatinine)
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Indicators of nutritional status measurements (creatinine in µmol/L) in serum of patients admitted to Intensive Care Unit (ICU).
  measure: Level of 25-hydroxyvitamin D
  time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
  description: Level of 25-hydroxyvitamin D measurements (in nmol/L) in serum of patients admitted to Intensive Care Unit (ICU).
  measure: Cumulative fluid balance (CFB)
  time frame: Every 24 hours until patient´s transport from the ICU
  description: Cumulative fluid balance daily measurements (in ml) in patients admitted to Intensive Care Unit (ICU).
  measure: Measurement of energy income
  time frame: Every 24 hours until patient´s transport from the ICU
  description: Measurement of daily energy income (in kcals) in patients admitted to Intensive Care Unit (ICU).
  measure: Measurement of protein income
  time frame: Every 24 hours until patient´s transport from the ICU
  description: Measurement of daily protein income (in g) in patients admitted to Intensive Care Unit (ICU).
  measure: Assessment of the presence of delirium (CAM-ICU test)
  time frame: Every 24 hours until patient´s transport from the ICU
  description: The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a simple and short test that enables continuous monitoring of the patients in conditions of ICU (measured as positive/negative).
  arm group label: Group of Patients who Survived (S)
  description: The group is defined by the number of patients who survived.
  arm group label: Group of Patients who Died (D)
  description: The group is defined by the number of patients who died.
  intervention type: Device
  intervention name: Bioelectrical impedance vector analysis (BIVA)
  description: BIVA is a simple, rapid, and noninvasive method, based on the principle that the flow of altering electrical current through a particular tissue differs depending on the content of water and electrolytes, used for monitoring hydratation and nutritional status in critically ill patients.
  arm group label: Group of Patients who Died (D)
  arm group label: Group of Patients who Survived (S)
  intervention type: Diagnostic Test
  intervention name: Blood and urine analysis
  description: For regular measurement in 2-3 terms, depending on the length of hospitalization (the first measurement took place within 48 hours of admission, followed one week after admission and the last before transport from the ICU): laboratory indicators of nutritional status will also be taken (albumin, prealbumin, creatinine), inflammation (C-reactive protein, presepsin) and 25-hydroxyvitamin D level.
  arm group label: Group of Patients who Died (D)
  arm group label: Group of Patients who Survived (S)
  intervention type: Diagnostic Test
  intervention name: cumulative water balance
  description: Cumulative balance is the sum of daily fluid balances during hospitalization.
  arm group label: Group of Patients who Died (D)
  arm group label: Group of Patients who Survived (S)
  Full blood and urine
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marcela Káňová, MD, Ph.D.
  role: Principal Investigator
  affiliation: University Hospital Ostrava
  facility: 
  country: Czechia
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  responsible party type: Sponsor
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  mesh term: Respiratory Distress Syndrome
  mesh term: Respiratory Distress Syndrome, Newborn
  mesh term: Respiratory Insufficiency
  mesh term: Water Intoxication
  mesh term: Hypoxia
  mesh term: Disease Progression
  sharing ipd: No
  ipd description: There is no plan to share individual participant data with other researchers.