NCT06180902 Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness
| NCT ID | NCT06180902 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology |
| Condition | Hypotension |
| Study Type | INTERVENTIONAL |
| Enrollment | 222 participants |
| Start Date | 2024-01-16 |
| Primary Completion | 2026-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 222 participants in total. It began in 2024-01-16 with a primary completion date of 2026-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Valery Likhvantsev, PhD
PRINCIPAL INVESTIGATOR
Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
Frequently Asked Questions
Who can join the NCT06180902 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypotension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06180902 currently recruiting?
Yes, NCT06180902 is actively recruiting participants. Contact the research team at lik0704@gmail.com for enrollment information.
Where is the NCT06180902 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT06180902 clinical trial?
NCT06180902 is sponsored by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology. The principal investigator is Valery Likhvantsev, PhD at Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology. The trial plans to enroll 222 participants.