Clinical trial NCT05991778: Bioelectrical Impedance in Monitoring Hyperhydration and Polyneuromyopathy in Critically Ill Patients
Official title: Bioelectrical Impedance Vector Analysis (BIVA) in Monitoring Hyperhydration and Polyneuromyopathy in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Acute
Respiratory Insufficiency
Lung Ventilator
Hyperhydration
Hypoxemia
Chronic Obstructive Pulmonary Disease Exacerbation
Septic Shock
Keywords: Bioelectrical impedance
Hyperhydration
Critical care
Extracorporeal membrane oxygenation Mortality
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill adult patients admitted to 24 beds ICU of the University Hospital with the development of ARDS and the assumption of at least 7 days of artificial lung ventilation (medical, trauma, surgical patients) at the time of admission to the ICU.

Informed consent was obtained from the person legally responsible for the patient.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Body Mass (physique) - Bioelectrical impedance analysis (BIA)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Body Mass (physique) - Phase Angle (PA)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Body Mass (physique) - BIVA vector analysis (Cole Cole graf)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
Secondary outcomes:
measure: Indicators of nutritional status (albumin, prealbumin)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Indicator of inflammation (CRP)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Indicator of inflammation - presepsin (PSEP)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
Other outcomes:
measure: Total body water (TBW)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Extracellular water (ECW)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Intracellular water (ICW)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Overhydration (OHY)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Ratio ECW/TBW
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Active body mass index (ATH)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Body mass index (BMI)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Body fat mass index (BFMI)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Fat-free mass index (FFMI)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Skeletal muscle mass (SMM)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Body cell mass (BCM)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Basal metabolic rate (BMR)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Nutric index (NI)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Prediction marker (PM)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Indicators of nutritional status (creatinine)
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Level of 25-hydroxyvitamin D
timeFrame: The first within 48 hours of admission, the second one week after admission and third before transport from the ICU
measure: Cumulative fluid balance (CFB)
timeFrame: Every 24 hours until patient´s transport from the ICU
measure: Measurement of energy income
timeFrame: Every 24 hours until patient´s transport from the ICU
measure: Measurement of protein income
timeFrame: Every 24 hours until patient´s transport from the ICU
measure: Assessment of the presence of delirium (CAM-ICU test)
timeFrame: Every 24 hours until patient´s transport from the ICU
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Czech Republic
Study officials:
affiliation: University Hospital Ostrava
name: Marcela Káňová, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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