Actively Recruiting
Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness
Led by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology · Updated on 2026-01-23
222
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 venous pressure (CVP) or pulmonary capillary wedge pressure (PCWP) persist in usage among certain traditionalists within the medical community. It must be noted that the patient's baseline state and the unique clinical context are pivotal in determining the precision of these methodologies. For example, the PLR test may yield limited information in fully conscious patients, and the prognostic value of CVP measurements is significantly diminished in cases of pneumothorax and hydrothorax. Regrettably, there is a paucity of data on the prognostic utility of these tests in patients with altered levels of consciousness, despite their growing presence in intensive care units. This gap underscores the necessity for comprehensive studies that evaluate the predictive efficacy of infusion therapy responsiveness in patients with concurrent hypotension and impaired consciousness. Purpose of the study: to investigate the sensitivity and specificity of methods for assessing fluid responsiveness in patients with hypotension and decreased level of consciousness.
CONDITIONS
Official Title
Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 265 18 years
- Hospitalization in an intensive care unit
- Level of consciousness on the FOUR scale 2612 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
You will not qualify if you...
- Pulmonary edema
- Absence of one or both lower extremities
- Chronic kidney disease according to KDIGO classification 263b stage
- Acute kidney injury grade 3
- Documented or suspected increased intracranial pressure (cerebral edema, brain compression, hydrocephalus, etc.)
- Presence of mitral valve regurgitation 261 grade 1
- Presence of aortic valve regurgitation 261 grade 1
- Patients previously enrolled in the "COMPASS" study in the period of 12 preceding hours
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
Moscow, Russia
Actively Recruiting
Research Team
V
Valery Likhvantsev, PhD
CONTACT
L
Levan Berikashvili, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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