Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06180902

Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness: A Comprehensive Crossover Study Examination

Led by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology · Updated on 2026-01-23

222

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effectiveness of various methods to assess fluid responsiveness in patients with hypotension and decreased levels of consciousness, a condition often seen in intensive care units. The study aims to determine the sensitivity and specificity of tests like inferior vena cava diameter measurements, passive leg raising (PLR) tests, and fluid challenges (FC) to better predict patient responses to infusion therapy. This research addresses the gap in data concerning patients with altered consciousness and aims to improve infusion therapy management in this vulnerable group. The study involves a sequence of assessments starting with measuring the diameter of the inferior vena cava, followed by central venous pressure evaluation. After a brief interval, the passive leg raising test is performed, then a 15-minute wait precedes the fluid challenge test. Following these assessments, participants receive a balanced crystalloid infusion of 1000 ml at a rate of 15 ml/kg/h, adjusted for any prior infusions during the fluid challenge. The study uses these methods to compare responses and evaluate fluid responsiveness. Participants will be monitored through various clinical measurements including blood pressures, central venous pressure, and cardiac output. Data collection includes detailed diagnostic test results such as true and false positives and negatives, with statistical analysis planned to evaluate diagnostic accuracy. The study follows participants through these assessments and infusion therapy to measure outcomes related to fluid responsiveness, with results assessed over an average of one year. Safety and adherence to protocols are monitored throughout the study period.

CONDITIONS

Brief Title

Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Hospitalized in an intensive care unit
  • Level of consciousness on the FOUR scale 12 points or less
  • Planned infusion therapy
  • Presence of a central venous catheter or a direct indication for catheterization
  • Medical council decision to include the patient in the study
Not Eligible

You will not qualify if you...

  • Pulmonary edema
  • Absence of one or both lower extremities
  • Chronic kidney disease stage 3b or higher according to KDIGO classification
  • Acute kidney injury grade 3
  • Documented or suspected increased intracranial pressure (such as cerebral edema, brain compression, hydrocephalus)
  • Mitral valve regurgitation greater than grade 1
  • Aortic valve regurgitation greater than grade 1
  • Previous enrollment in the "COMPASS" study within the past 12 hours

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Diagnostic Evaluation

Duration - Approximately 1 day

Participants undergo a series of diagnostic tests to assess fluid responsiveness. This includes measuring the diameter of the inferior vena cava, evaluating central venous pressure, performing the passive leg raise test, and conducting a fluid challenge test.

1 visit (in-person)

Fluid Infusion

Duration - Single session with infusion and monitoring

After diagnostic testing, participants receive a balanced crystalloid solution infusion of 1000 ml at 15 ml/kg/hour, adjusted for any prior infusions during the fluid challenge. The effectiveness of infusion therapy is then evaluated by reassessing cardiac output.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology

Moscow, Russia

Actively Recruiting

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Research Team

V

Valery Likhvantsev, PhD

L

Levan Berikashvili, MD

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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