Assessing fluid responsiveness in patients with impaired consciousness
Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness: A Comprehensive Crossover Study Examination
This study tests different ways to see how well patients with low blood pressure and impaired consciousness respond to fluid treatment in order to improve their care in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 222 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06180902 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of various methods for assessing fluid responsiveness in patients experiencing hypotension and cognitive impairment. It employs tests such as evaluating the inferior vena cava's diameter, passive leg raising (PLR), and fluid challenge (FC) to determine how well patients respond to infusion therapy. The study aims to address the limitations of traditional static measurements like central venous pressure (CVP) and pulmonary capillary wedge pressure (PCWP), particularly in patients with altered consciousness levels. By focusing on more accessible and cost-effective methods, the research seeks to improve management strategies for hypotension in intensive care settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are hospitalized in an intensive care unit with arterial hypotension and impaired consciousness.
Not a fit: Patients with pulmonary edema, severe chronic kidney disease, or increased intracranial pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of hypotension in critically ill patients, leading to better clinical outcomes.
How similar studies have performed: While traditional methods have been questioned, the use of PLR and FC tests has shown promise in other studies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Moscow
- Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Valery Likhvantsev, PhD — Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
- Study coordinator: Valery Likhvantsev, PhD
- Email: lik0704@gmail.com
- Phone: +79036235982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.