CompletedNot Applicable

Bioelectrical Impedance in Monitoring Hyperhydration and Polyneuromyopathy in Critically Ill Patients

Czechia61 participantsStarted 2021-03-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

Trial details

NCT IDNCT05991778

SponsorUniversity Hospital Ostrava

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-31

View on ClinicalTrials.gov More Respiratory Distress Syndrome, Acute trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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