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NCT Number: NCT05991778

Bioelectrical Impedance in Monitoring Hyperhydration and Polyneuromyopathy in Critically Ill Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with respiratory insufficiency, with the assumption of at least 7 days of artificial lung ventilation (medical, trauma, surgical patients)
  • Primary acute respiratory distress syndrome (ARDS) (pulmonary involvement): pneumonia, inhalation trauma, chest trauma (lung contusion), aspiration
  • Secondary ARDS (extrapulmonary): sepsis, shock states, acute pancreatitis, polytrauma, burns, non-cardiogenic shock, intoxication, TRALI (massive blood transfusion), drowning
  • Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD)

Exclusion criteria

  • Patients with unfavorable prognosis
  • APACHE II ≥30
  • Metastatic malignancy
  • Conditions after cardiopulmonary resuscitation (KPCR) before admission
  • Cerebral edema
  • Brain trauma
  • Intracranial hypertension
  • Liver cirrhosis
  • A pre-existing neurodegenerative disease
  • Patients with pacemakers, defibrillators, pregnancy (conditions contraindications to use of bio-electrical impedance).

Treatment and study plan

Bioelectrical impedance vector analysis (BIVA)

Device

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.

Blood and urine analysis

Diagnostic Test

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.

cumulative water balance

Diagnostic Test

Cumulative balance is the sum of daily fluid balances during hospitalization.

Primary outcomes

  1. 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

    Bioelectrical impedance analysis (BIA) comparison of skeletal muscle mass, body fat and body water (expressed in %) in patients hospitalized in the ICU.

  2. 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

    Assessment of the Phase angle (expressed in degrees) as a part of BIA in patients hospitalized in the ICU.

  3. 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

    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.

Secondary outcomes

  1. 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

    Assesment of indicators of nutritional status (albumin, prealbumin in g/l) in serum of patients admitted to Intensive Care Unit (ICU).

  2. 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

    Assesment of indicator of inflammation (C-reactive protein in mg/L) in serum of patients admitted to Intensive Care Unit (ICU).

  3. 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

    Assesment of indicator of inflammation measurements (presepsin in ng/L) in serum of patients admitted to Intensive Care Unit (ICU).

Other outcomes

  1. 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

    Total body water measurements (in %) in patients admitted to Intensive Care Unit (ICU).

  2. 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

    Extracellular water measurements (in %) in patients admitted to Intensive Care Unit (ICU).

  3. 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

    Intracellular water measurements (in %) in patients admitted to Intensive Care Unit (ICU).

  4. Overhydration (OHY)

    Time frame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU

    Overhydration measurements (in %) in patients admitted to Intensive Care Unit (ICU).

  5. 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

    Ratio ECW/TBW measurements (in %) in patients admitted to Intensive Care Unit (ICU).

  6. 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

    Active body mass index measurements (in kg/m2) in patients admitted to Intensive Care Unit (ICU).

  7. 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

    Body mass index measurements (in kg/m2) in patients admitted to Intensive Care Unit (ICU).

  8. 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

    Body fat mass index measurements (in kg/m2) in patients admitted to Intensive Care Unit (ICU).

  9. 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

    Fat-free mass index measurements (in kg/m2) in patients admitted to Intensive Care Unit (ICU).

  10. 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

    Skeletal muscle mass measurements (in kg) in patients admitted to Intensive Care Unit (ICU).

  11. 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

    Body cell mass measurements (in kg) in patients admitted to Intensive Care Unit (ICU).

  12. 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

    Basal metabolic rate measurements (in kcal) in patients admitted to Intensive Care Unit (ICU).

  13. 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

    Nutric index measurements (in %) in patients admitted to Intensive Care Unit (ICU).

  14. 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

    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.

  15. 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

    Indicators of nutritional status measurements (creatinine in µmol/L) in serum of patients admitted to Intensive Care Unit (ICU).

  16. 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

    Level of 25-hydroxyvitamin D measurements (in nmol/L) in serum of patients admitted to Intensive Care Unit (ICU).

  17. Cumulative fluid balance (CFB)

    Time frame: Every 24 hours until patient´s transport from the ICU

    Cumulative fluid balance daily measurements (in ml) in patients admitted to Intensive Care Unit (ICU).

  18. Measurement of energy income

    Time frame: Every 24 hours until patient´s transport from the ICU

    Measurement of daily energy income (in kcals) in patients admitted to Intensive Care Unit (ICU).

  19. Measurement of protein income

    Time frame: Every 24 hours until patient´s transport from the ICU

    Measurement of daily protein income (in g) in patients admitted to Intensive Care Unit (ICU).

  20. Assessment of the presence of delirium (CAM-ICU test)

    Time frame: Every 24 hours until patient´s transport from the ICU

    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).

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

Bioelectrical Impedance Vector Analysis (BIVA) in Monitoring Hyperhydration and Polyneuromyopathy in Critically Ill Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 15, 2023
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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