HypotensionNCT06180902
Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness
A study testing Inferior vena cava's diameter ratio, Central venous pressure and Passive leg raising test in people with Hypotension and Cognitive Impairment, run by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Cognitive Impairment
- What is being tested?
- Inferior vena cava's diameter ratio, Central venous pressure and Passive leg raising test
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteRussia
- Study dates
- 16 Jan 2024to 20 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
Moscow
Valery Likhvantsev, PhD, +79036235982, lik0704@gmail.com
Levan Berikashvili, MD, +79263308968, levan.berikashvili@mail.ru
About this study
Official title: Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness: A Comprehensive Crossover Study Examination
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.
Read more
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.
Read the detailed description
Hypotension often precedes adverse clinical outcomes, prompting an investigation into the efficacy of infusion therapy in its management. The study employs a variety of tests for assessment, including evaluation of the inferior vena cava's collapsibility and distensibility indices, passive leg raise (PLR) tests, and fluid challenge (FC) procedures.
Dynamic testing methods, including systolic pressure variability (SPV), pulse pressure variability (PPV), and stroke volume variability (SVV), offer predictions of real-time responses to infusion therapy. However, the high costs of the necessary equipment restrict widespread application. In contrast, passive leg raise (PLR) and fluid challenge (FC) tests are more accessible due to lower costs.
Despite skepticism in various clinical protocols regarding reliability, traditional measures such as central venous pressure (CVP) and pulmonary capillary wedge pressure (PCWP) continue to be favored in certain medical circles. Considering the patient's baseline condition and specific clinical context is critical when applying such methods. For instance, the PLR test may be less informative in fully conscious patients, and the value of CVP measurements decreases in cases like pneumothorax and hydrothorax.
A notable deficiency exists in data concerning the prognostic value of tests in patients with altered consciousness levels, a scenario frequently encountered in intensive care settings. This situation underscores the urgent need for comprehensive research into the predictive accuracy of infusion therapy response in patients who have coexisting hypotension and impaired consciousness.
The study aims to examine the sensitivity and specificity of fluid responsiveness assessment methods in hypotensive patients with reduced consciousness. The protocol begins by measuring the diameter of the inferior vena cava, followed by an evaluation of central venous pressure. After a brief interval, the passive leg raise (PLR) test is performed, succeeded by a 15-minute waiting period. Subsequently, an infusion load test is carried out. Next, a balanced crystalloid solution of 1000 ml at a rate of 15 ml/kg/h is administered, taking into account any previous infusions during the fluid challenge.
In the study, adherence to the intention-to-treat principle is planned for all analyses. Data distribution will be assessed using the Kolmogorov-Smirnov test with Lilliefors correction or the Shapiro-Wilk test. Descriptive data will be presented as percentages, means ± SD for normally distributed variables, or medians ± interquartile ranges for non-normally distributed variables. Qualitative characteristics will be reported as frequencies. P-values and confidence intervals will be provided for all comparative outcomes between two groups. All statistical tests will be two-tailed, with a significance threshold set at p < 0.05.
Outcomes for all binary variables, including primary and secondary outcomes, will be compared using the Chi-square test or Fisher's exact test, accounting for stratification variables. Comparative intergroup analysis of quantitative variables will be based on the Mann-Whitney U test or Student's t-test, depending on data distribution characteristics. Baseline data will include diagnostic test results such as true positives, true negatives, false positives, and false negatives. Diagnostic accuracy will be assessed using Area Under the Receiver Operating Characteristic curve (AUROC) and Area Under the Precision-Recall curve (AUPC). AUROC comparisons will be made using the DeLong method, with the optimal cutoff in ROC analysis determined according to Youden's index. Sensitivity, specificity, and predictive values of positive and negative results will also be evaluated. Cohen's Kappa will be used to assess test consistency.
- Conditions
- Hypotension, Cognitive Impairment
- Being tested
- Inferior vena cava's diameter ratio, Central venous pressure, Passive leg raising test, Fluid challenge, Fluid infusion
- Keywords
- Hypotension, Cognitive Impairment, Fluid Responsiveness, Intensive Care, Fluid Infusion
- Medical subject headings
- Hypotension, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior vena cava's diameter ratioDiagnostic test
In mechanical ventilation, the Inferior Vena Cava's maximum diameter (IVCmax) is measured at peak inspiration, and minimum diameter (IVCmin) at expiration's end. The Distensibility Index (IVCDI) is calculated as [(IVCmax - IVCmin) / IVCmin] × 100%. In spontaneous breathing, IVCmax is the diameter at expiration's end, and IVCmin at inspiration's end. The Collapse Index (IVCCI) is [(IVCmax - IVCmin) / IVCmax] × 100%.
Clinically, an IVCDI/IVCCI ≥ 18% indicates a 'responder'. Values < 18% denote 'non-responders'.
Central venous pressureDiagnostic test
In our protocol, patients lie flat, connected to a saline-filled system for intravenous infusion via a central venous catheter. The system, starting from the subclavian catheter, extends to the 2nd to 3rd intercostal space at the mid-axillary line. The tube's end is raised perpendicular to the bed until saline flow stops, marking the liquid level. The height from the mid-axillary line to this point is measured in millimeters. If the liquid column falls below the mid-axillary line, indicating continuous flow, the CVP is negative, and the catheter is closed to block air entry. CVP readings are taken at exhalation's end.
CVP interpretation:
- CVP ≤ 12 mmHg (16.3 cm H2O) indicates a responder.
- CVP > 12 mmHg (16.3 cm H2O) indicates a non-responder.
Passive leg raising testDiagnostic test
Also called PLR-test
In our protocol, the patient starts flat for initial CVP measurement. Then, the bed is tilted to 45 degrees for the first measurements: Systolic/Diastolic Blood Pressure, Mean Arterial Pressure, and Pulse Pressure (Systolic - Diastolic). Next, the bed is adjusted to elevate the feet, creating a 135-degree angle between torso and legs. After 90 seconds, the second set of measurements, including CVP, is taken. The patient is then returned to the initial position.
Interpreting results:
A responder is indicated by:
- Over 10% Pulse Pressure (PP) increase in the second measurement;
- The ratio of PP change to CVP change (∆PP / ∆CVP) > 1;
- Second measurement CVP ≤ 12 mmHg (16.3 cm H2O).
A non-responder is indicated by the presence at least one of the following:
- Less than 10% PP increase in the second measurement;
- The ratio of PP change to CVP change (∆PP / ∆CVP) ≤ 1;
- Second measurement CVP > 12 mmHg (16.3 cm H2O).
Fluid challengeDiagnostic test
Also called FC
In our clinical procedure, patients start horizontally for initial measurements: Systolic, Diastolic, Mean Arterial, Pulse Blood Pressures, and Central Venous Pressure (CVP). Then, they receive a balanced crystalloid solution at 4 ml/kg body weight at maximum permissible infusion rate. After infusion, a second measurement set identical to the first is taken.
Interpretation:
A responder is indicated by:
- Pulse Pressure (PP) increase > 10% in second measurement;
- Ratio of PP change to CVP change (∆PP / ∆CVP) > 1;
- Second CVP measurement ≤ 12 mmHg (16.3 cm H2O).
A non-responder is indicated by the presence at least one of the following:
- PP increase < 10% in second measurement;
- Ratio of PP change to CVP change (∆PP / ∆CVP) ≤ 1;
- Second CVP measurement > 12 mmHg (16.3 cm H2O).
Fluid infusionProcedure or surgery
After assessing infusion therapy responsiveness, patients receive balanced crystalloid solutions at 1000 ml, infused at 15 ml/kg/hour, accounting for any prior infusions. Effectiveness evaluation follows, involving cardiac output reassessment (initially measured upon study enrollment). Effectiveness is determined by a ≥10% increase in cardiac output in the second measurement compared to the first. This is quantified as: [(CO(after) - CO(before)) / CO(before)] × 100% ≥ 10%, where CO(after) is the post-infusion cardiac output and CO(before) the pre-infusion output.
| Study group | Role | What they receive |
|---|---|---|
| Fluid responsiveness testing | Experimental | In our clinical study to evaluate infusion therapy responsiveness, we'll start by measuring the inferior vena cava diameter. Two minutes later, we'll assess central venous pressure. After another two-minute pause, the passive leg raise test begins, followed by a 15-minute wait. Then, we conduct the fluid challenge. Post-evaluation, we administer balanced crystalloid solutions at 1000 ml, infused at 15 ml/kg/h, adjusting for any previous infusions during the fluid challenge. Receives: Diagnostic Test: Inferior vena cava's diameter ratio; Diagnostic Test: Central venous pressure; Diagnostic Test: Passive leg raising test; Diagnostic Test: Fluid challenge; Procedure: Fluid infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of methods for assessing fluid responsiveness
Sensitivity - proportion of actual positives that are correctly identified by the test.
Specificity - proportion of actual negatives that are correctly identified by the test.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start16 Jan 2024
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- For all patients included in the study, a designated algorithm will be applied. The initial phase of the clinical study, aimed at evaluating responsiveness to infusion therapy, starts with a precise measurement of the inferior vena cava's diameter. After a brief two-minute interval subsequent to the measurement, the focus shifts to the assessment of central venous pressure. A further two-minute pause following the central venous pressure evaluation signals the commencement of the passive leg raise test, an essential element in the protocol. The conclusion of the passive leg raise test is followed by a fifteen-minute waiting period, which precedes the start of the fluid challenge, completing the thorough evaluation sequence.
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valery Likhvantsev, Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
- Investigators
- Valery Likhvantsev, PhD, Principal investigator, Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180902
- Sponsor's protocol ID
- COMPASS
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness: A Comprehensive Crossover Study Examination
- ClinicalTrials.gov ID
- NCT06180902
- Acronym / sponsor ID
- COMPASS
- Conditions
- Hypotension, Cognitive Impairment
- Keywords
- Hypotension, Cognitive Impairment, Fluid Responsiveness, Intensive Care, Fluid Infusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Federal Research and Clinical Centre of Intensive Care Medicine and RehabilitologyUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypotension often precedes adverse clinical outcomes, prompting an investigation into the efficacy of infusion therapy in its management. The study employs a variety of tests for assessment, including evaluation of the inferior vena cava's collapsibility and distensibility indices, passive leg raise (PLR) tests, and fluid challenge (FC) procedures.
Dynamic testing methods, including systolic pressure variability (SPV), pulse pressure variability (PPV), and stroke volume variability (SVV), offer predictions of real-time responses to infusion therapy. However, the high costs of the necessary equipment restrict widespread application. In contrast, passive leg raise (PLR) and fluid challenge (FC) tests are more accessible due to lower costs.
Despite skepticism in various clinical protocols regarding reliability, traditional measures such as central venous pressure (CVP) and pulmonary capillary wedge pressure (PCWP) continue to be favored in certain medical circles. Considering the patient's baseline condition and specific clinical context is critical when applying such methods. For instance, the PLR test may be less informative in fully conscious patients, and the value of CVP measurements decreases in cases like pneumothorax and hydrothorax.
A notable deficiency exists in data concerning the prognostic value of tests in patients with altered consciousness levels, a scenario frequently encountered in intensive care settings. This situation underscores the urgent need for comprehensive research into the predictive accuracy of infusion therapy response in patients who have coexisting hypotension and impaired consciousness.
The study aims to examine the sensitivity and specificity of fluid responsiveness assessment methods in hypotensive patients with reduced consciousness. The protocol begins by measuring the diameter of the inferior vena cava, followed by an evaluation of central venous pressure. After a brief interval, the passive leg raise (PLR) test is performed, succeeded by a 15-minute waiting period. Subsequently, an infusion load test is carried out. Next, a balanced crystalloid solution of 1000 ml at a rate of 15 ml/kg/h is administered, taking into account any previous infusions during the fluid challenge.
In the study, adherence to the intention-to-treat principle is planned for all analyses. Data distribution will be assessed using the Kolmogorov-Smirnov test with Lilliefors correction or the Shapiro-Wilk test. Descriptive data will be presented as percentages, means ± SD for normally distributed variables, or medians ± interquartile ranges for non-normally distributed variables. Qualitative characteristics will be reported as frequencies. P-values and confidence intervals will be provided for all comparative outcomes between two groups. All statistical tests will be two-tailed, with a significance threshold set at p < 0.05.
Outcomes for all binary variables, including primary and secondary outcomes, will be compared using the Chi-square test or Fisher's exact test, accounting for stratification variables. Comparative intergroup analysis of quantitative variables will be based on the Mann-Whitney U test or Student's t-test, depending on data distribution characteristics. Baseline data will include diagnostic test results such as true positives, true negatives, false positives, and false negatives. Diagnostic accuracy will be assessed using Area Under the Receiver Operating Characteristic curve (AUROC) and Area Under the Precision-Recall curve (AUPC). AUROC comparisons will be made using the DeLong method, with the optimal cutoff in ROC analysis determined according to Youden's index. Sensitivity, specificity, and predictive values of positive and negative results will also be evaluated. Cohen's Kappa will be used to assess test consistency.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For all patients included in the study, a designated algorithm will be applied. The initial phase of the clinical study, aimed at evaluating responsiveness to infusion therapy, starts with a precise measurement of the inferior vena cava's diameter. After a brief two-minute interval subsequent to the measurement, the focus shifts to the assessment of central venous pressure. A further two-minute pause following the central venous pressure evaluation signals the commencement of the passive leg raise test, an essential element in the protocol. The conclusion of the passive leg raise test is followed by a fifteen-minute waiting period, which precedes the start of the fluid challenge, completing the thorough evaluation sequence.
| Arm | Type | Receives |
|---|---|---|
| Fluid responsiveness testing | Experimental | Diagnostic Test: Inferior vena cava's diameter ratio, Diagnostic Test: Central venous pressure, Diagnostic Test: Passive leg raising test, Diagnostic Test: Fluid challenge, Procedure: Fluid infusionIn our clinical study to evaluate infusion therapy responsiveness, we'll start by measuring the inferior vena cava diameter. Two minutes later, we'll assess central venous pressure. After another two-minute pause, the passive leg raise test begins, followed by a 15-minute wait. Then, we conduct the fluid challenge. Post-evaluation, we administer balanced crystalloid solutions at 1000 ml, infused at 15 ml/kg/h, adjusting for any previous infusions during the fluid challenge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inferior vena cava's diameter ratioIn mechanical ventilation, the Inferior Vena Cava's maximum diameter (IVCmax) is measured at peak inspiration, and minimum diameter (IVCmin) at expiration's end. The Distensibility Index (IVCDI) is calculated as [(IVCmax - IVCmin) / IVCmin] × 100%. In spontaneous breathing, IVCmax is the diameter at expiration's end, and IVCmin at inspiration's end. The Collapse Index (IVCCI) is [(IVCmax - IVCmin) / IVCmax] × 100%. Clinically, an IVCDI/IVCCI ≥ 18% indicates a 'responder'. Values < 18% denote 'non-responders'. | Diagnostic test | Fluid responsiveness testing |
| Central venous pressureIn our protocol, patients lie flat, connected to a saline-filled system for intravenous infusion via a central venous catheter. The system, starting from the subclavian catheter, extends to the 2nd to 3rd intercostal space at the mid-axillary line. The tube's end is raised perpendicular to the bed until saline flow stops, marking the liquid level. The height from the mid-axillary line to this point is measured in millimeters. If the liquid column falls below the mid-axillary line, indicating continuous flow, the CVP is negative, and the catheter is closed to block air entry. CVP readings are taken at exhalation's end. CVP interpretation: * CVP ≤ 12 mmHg (16.3 cm H2O) indicates a responder. * CVP > 12 mmHg (16.3 cm H2O) indicates a non-responder. | Diagnostic test | Fluid responsiveness testing |
| Passive leg raising testAlso: PLR-testIn our protocol, the patient starts flat for initial CVP measurement. Then, the bed is tilted to 45 degrees for the first measurements: Systolic/Diastolic Blood Pressure, Mean Arterial Pressure, and Pulse Pressure (Systolic - Diastolic). Next, the bed is adjusted to elevate the feet, creating a 135-degree angle between torso and legs. After 90 seconds, the second set of measurements, including CVP, is taken. The patient is then returned to the initial position. Interpreting results: A responder is indicated by: * Over 10% Pulse Pressure (PP) increase in the second measurement; * The ratio of PP change to CVP change (∆PP / ∆CVP) > 1; * Second measurement CVP ≤ 12 mmHg (16.3 cm H2O). A non-responder is indicated by the presence at least one of the following: * Less than 10% PP increase in the second measurement; * The ratio of PP change to CVP change (∆PP / ∆CVP) ≤ 1; * Second measurement CVP > 12 mmHg (16.3 cm H2O). | Diagnostic test | Fluid responsiveness testing |
| Fluid challengeAlso: FCIn our clinical procedure, patients start horizontally for initial measurements: Systolic, Diastolic, Mean Arterial, Pulse Blood Pressures, and Central Venous Pressure (CVP). Then, they receive a balanced crystalloid solution at 4 ml/kg body weight at maximum permissible infusion rate. After infusion, a second measurement set identical to the first is taken. Interpretation: A responder is indicated by: * Pulse Pressure (PP) increase > 10% in second measurement; * Ratio of PP change to CVP change (∆PP / ∆CVP) > 1; * Second CVP measurement ≤ 12 mmHg (16.3 cm H2O). A non-responder is indicated by the presence at least one of the following: * PP increase < 10% in second measurement; * Ratio of PP change to CVP change (∆PP / ∆CVP) ≤ 1; * Second CVP measurement > 12 mmHg (16.3 cm H2O). | Diagnostic test | Fluid responsiveness testing |
| Fluid infusionAfter assessing infusion therapy responsiveness, patients receive balanced crystalloid solutions at 1000 ml, infused at 15 ml/kg/hour, accounting for any prior infusions. Effectiveness evaluation follows, involving cardiac output reassessment (initially measured upon study enrollment). Effectiveness is determined by a ≥10% increase in cardiac output in the second measurement compared to the first. This is quantified as: [(CO(after) - CO(before)) / CO(before)] × 100% ≥ 10%, where CO(after) is the post-infusion cardiac output and CO(before) the pre-infusion output. | Procedure or surgery | Fluid responsiveness testing |
Primary outcome
Sensitivity and specificity of methods for assessing fluid responsiveness
Time frame: Through study completion, an average of 1 year
Sensitivity - proportion of actual positives that are correctly identified by the test. Specificity - proportion of actual negatives that are correctly identified by the test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valery Likhvantsev, PhD principal investigator
Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior vena cava's diameter ratio, Central venous pressure and Passive leg raising test in people with Hypotension and Cognitive Impairment, run by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valery Likhvantsev, PhD (+79036235982, lik0704@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of methods for assessing fluid responsiveness (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.