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Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness

RecruitingNAAges 18 Years - anyAllFederal Research and Clinical Centre of Intensive…
NCT06180902 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Hypotension is a significant precursor to unfavorable clinical outcomes. To determine whether infusion therapy can positively impact the management of hypotension, several evaluative tests can be utilized. These include assessing the collapsibility and distensibility indices of the inferior vena cava, conducting a passive leg raising (PLR) test, and performing a fluid challenge (FC). Technologically advanced methods leveraging dynamic testing are capable of real-time prediction of a patient's response to infusion therapy. Nonetheless, the use of systolic pressure variability (SPV), pulse pressure variability (PPV), and stroke volume variability (SVV) is often limited by the prohibitive costs of the necessary equipment. In contrast, the PLR test and FC are not subject to this limitation. Despite being deemed unreliable by numerous clinical protocols, static measurements of central venou

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years. * Hospitalization in an intensive care unit * Level of consciousness on the FOUR scale ≤ 12 points * Planned infusion therapy * Presence of a central venous catheter or direct indication for catheterization * The decision of the medical council to include the patient in the study Exclusion Criteria: * Pulmonary edema * Absence of one or both lower extremities * Chronic kidney disease according to KDIGO classification ≥ stage 3b * Acute kidney injury grade 3 * Documented or suspected increased intracranial pressure (cerebral edema, brain compression, hydrocephalus, etc.). * Presence of mitral valve regurgitation \> grade 1 * Presence of aortic valve regurgitation \> grade 1 * Patients previously enrolled in the "COMPASS" study in the period of 12 preceding hours
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What it tests

  • Inferior vena cava's diameter ratio
  • Central venous pressure
  • Passive leg raising test
  • Fluid challenge
  • Fluid infusion
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Where

1 site
Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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