Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness

Recruiting now · Not applicable

Conditions studied: Hypotension, Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT06180902

Run by

Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

People needed

222

Starts

2024-01-16

Expected to finish

2026-05-20

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology — Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

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