Bioelectrical Impedance in Monitoring Hyperhydration and Polyneuromyopathy in Critically Ill Patients

NCT05991778 | Completed

• 2 other identifiers: KARIM-2022-BIVASGS09/LF/2022
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Body Mass (physique) - Bioelectrical impedance analysis (BIA)

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

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

• Body Mass (physique) - Phase Angle (PA)

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

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

• Body Mass (physique) - BIVA vector analysis (Cole Cole graf)

  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.

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

Secondary Outcomes (3)

• Indicators of nutritional status (albumin, prealbumin)

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

• Indicator of inflammation (CRP)

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

• Indicator of inflammation - presepsin (PSEP)

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

Other Outcomes (20)

• Total body water (TBW)

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

• Extracellular water (ECW)

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

• Intracellular water (ICW)

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

Study Arms (2)

Group of Patients who Survived (S)

The group is defined by the number of patients who survived.

Device: Bioelectrical impedance vector analysis (BIVA); Diagnostic Test: Blood and urine analysis; Diagnostic Test: cumulative water balance

Group of Patients who Died (D)

The group is defined by the number of patients who died.

Device: Bioelectrical impedance vector analysis (BIVA); Diagnostic Test: Blood and urine analysis; Diagnostic Test: cumulative water balance

Interventions

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.

Group of Patients who Died (D); Group of Patients who Survived (S)

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.

Group of Patients who Died (D); Group of Patients who Survived (S)

cumulative water balance DIAGNOSTIC_TEST

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

Group of Patients who Died (D); Group of Patients who Survived (S)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Czech Republic, 70852, Czechia

Location

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Full blood and urine

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency; Water Intoxication; Hypoxia; Shock, Septic

Interventions

Blood Specimen Collection; Urinalysis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Poisoning; Chemically-Induced Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Shock

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Clinical Chemistry Tests; Diagnostic Techniques, Urological

Study Officials

• Marcela Káňová, MD, Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 15, 2023
• Study Start: March 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)