Fluid ResponsivenessNCT02789124
Diagnostic Value of Passive Leg Raise Induced Changes in Carotid Artery Flow Time to Predict Fluid Responsiveness in Critically Ill Patients
A study testing Carotid Doppler Measurement in response to passive leg raise in people with Fluid Responsiveness and Carotid Artery Flow Time, run by University of Louisville at 1 site in United States.
Trial summary
Difficulties in the accurate assessment of intravascular volume in critically ill patients are frequently encountered. In addition to clinical evaluation, bedside echocardiographic measurements of fluid responsiveness can be technically difficult, especially in critically ill mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Responsiveness, Carotid Artery Flow Time, Passive Leg Raise
- What is being tested?
- Carotid Doppler Measurement in response to passive leg raise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 or older,
- admitted to ICU and already have an arterial line and Flotrac/Vigileo monitor in place ordered by primary team as part of their clinical standard practice.
Who cannot join
- Not in sinus rhythm,
- clinically suspected or known intraabdominal hypertension,
- lower extremity amputee,
- femoral arterial line,
- poor or unreliable arterial line waveform,
- history of carotid endarterectomy in the artery being measured,
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Difficulties in the accurate assessment of intravascular volume in critically ill patients are frequently encountered. In addition to clinical evaluation, bedside echocardiographic measurements of fluid responsiveness can be technically difficult, especially in critically ill mechanically ventilated patients. The carotid artery is an easily accessible structure that is amenable to bedside ultrasonography performed by Intensivists. The investigators hypothesize that measurement of the carotid artery Corrected Flow Time (FTC) in response to a passive leg raise (PLR), which simulates a fluid bolus, can be used to predict fluid responsiveness.
Read the detailed description
Predicting fluid responsiveness in the Intensive Care Unit (ICU) is a difficult task. Clearly, early aggressive resuscitation in patients with severe sepsis and septic shock improves outcomes. Conversely, overzealous fluid administration is associated with increased mortality in patients with septic shock and acute lung injury. However, recent studies have challenged conventional wisdom that clinical exam, central venous pressure (CVP), or pulmonary artery occlusion pressure (PAOP) are able to predict volume status or fluid responsiveness.
Only approximately 50% of ICU patients have been shown to respond to volume expansion in studies designed to examine fluid responsiveness.9 Ideally, Intensivists would have access to a cheap, reliable, continuously operating, non-invasive, and user friendly device so that fluid could be administered until their patient is no longer fluid responsive. Stroke volume could be maximized via the Frank-Starling relationship and over resuscitation with its potential deleterious effects could be avoided. Although measurement of thermodilution cardiac output by the Pulmonary Artery Catheter (PAC) is considered the "gold standard" by which new devices are validated, it has a waning role in modern ICUs. Existing technologies such as Esophageal Doppler, Transpulmonary Indicator Dilution, and Arterial-Pressure-Waveform-Derived methods, while not as invasive as a PAC, are still invasive procedures. Echocardiography is an excellent tool, however assessing for fluid responsiveness requires advanced training beyond a qualitative approach and it can be difficult to obtain optimal windows in critically ill patients. Thus, current methods for assessment of fluid responsiveness are suboptimal.
The use of Carotid Doppler to determine volume responsiveness has recently been proposed. Remarkably, the authors found that an increase in carotid blood flow of 20% predicted fluid responsiveness with a sensitivity of 94% and specificity of 86%. This appears to be an attractive option, with the caveats that not all point of care ultrasound machines currently available have the software capability to calculate carotid artery velocity time integral (VTI) and this method was validated using Bioreactance, the reliability of which has been recently questioned. A more simple method of evaluating the carotid artery for fluid responsiveness, the Carotid Flow Time, was recently discussed on a popular ultrasound podcast, but has not yet been validated in a clinical study.
The Carotid Artery Corrected Flow Time (FTC) concept is not new. In fact, it has been well studied as a marker of preload and afterload with Transesophageal Doppler (TED). TED monitors display a wave form of the velocity versus time similar to the image one might obtain doing pulsed wave Doppler (PWD) of the carotid artery. With TED, the waveform has a triangular appearance. The apex of the triangle represents peak velocity, which along with mean acceleration reflects cardiac contractility. The area under the systolic portion of the curve is equal to stroke distance, and when multiplied by the cross sectional area of the descending aorta this value can be used to estimate cardiac output predicated on the assumption that the descending aorta receives 70% of cardiac output. The investigators are interested in the base of the triangle representing systolic ejection time. When corrected for heart rate by dividing by the square root of cardiac cycle time we have the FTC. The FTC would be expected to increase with enhanced preload or reduction in afterload; conversely it should decrease with a reduction in preload or increase in afterload. One study performed in 20 neurosurgical patients with TED showed that the FTC was able to predict fluid responsiveness when used as a static measure with a cutoff of 357 ms prior to loading with 7 ml/kg of hydroxyethyl starch solution. The area under the receiver operating curve (ROC) was 0.944.
The investigators believe that the concept of FTC as a marker of preload can be combined conveniently with PWD of the carotid artery and a passive leg raising maneuver (PLR) to estimate fluid responsiveness in critically ill patients. The method is very attractive due to the ease of access to the carotid artery, reproducibility, low cost, and since the FTC is a measurement of time (not velocity), the angle of insonation should be inconsequential, making the exam technically easier to perform compared to carotid artery VTI. This can be compared to a 10% increase in SVI following a PLR demonstrated by the Flotrac/Vigileo being considered the "gold standard". While the absolute values of cardiac output obtained with the Flotrac/Vigileo when compared with the PAC are debatable, the ability of the device to track changes in cardiac output/stroke volume in response to changes in preload and PLR have been shown to be accurate.16-19 A meta-analysis published by Cavallaro and colleagues showed that PLR induced changes in cardiac output were able to predict fluid responsiveness with a sensitivity and specificity of 89.4% and 91.4% with a pooled area under the ROC value of 0.95 regardless of ventilation mode, underlying cardiac rhythm, and technique of measurement. Thus, an increase in SVI > 10% with PLR detected by a Flotrac/Vigileo monitor without the need for a fluid bolus, should be sufficient to determine whether PLR induced changes in carotid FTC are able to detect fluid responsiveness.
- Being tested
- Carotid Doppler Measurement in response to passive leg raise
- Keywords
- fluid responsiveness, carotid artery flow time, passive leg raise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Doppler Measurement in response to passive leg raiseOther
The investigators will measure Carotid Flow time in the semi-recumbent position, then lay the patient flat and do a passive leg raise. The investigators will then meausre Carotid Flow Time at 1 minute, 2 minutes, and 3 minutes. Patients who have 10 % increase in stroke volume on the Flotrac / Vigileo monitor will be considered fluid responders. The investigators will try to identify an optimum % increase of Carotid Flow Time that can predict fluid responsiveness.
| Study group | Role | What they receive |
|---|---|---|
| Carotid Artery Flow Time | Experimental | Patients with radial aline and flotrac vigileo will have carotid dopper measured for carotid flow time and a passive leg raise Receives: Other: Carotid Doppler Measurement in response to passive leg raise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid Responsiveness
Passive leg raise induced increase in stroke volume of 10% on vigileo monitor
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startJun 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Saad, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789124
- Sponsor's protocol ID
- 14.0272
- Status last verified
- Jun 2016
- First submitted
- 4 Feb 2015
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Passive Leg Raise Induced Changes in Carotid Artery Flow Time to Predict Fluid Responsiveness in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02789124
- Acronym / sponsor ID
- 14.0272
- Keywords
- fluid responsiveness, carotid artery flow time, passive leg raise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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.
Difficulties in the accurate assessment of intravascular volume in critically ill patients are frequently encountered. In addition to clinical evaluation, bedside echocardiographic measurements of fluid responsiveness can be technically difficult, especially in critically ill mechanically ventilated patients. The carotid artery is an easily accessible structure that is amenable to bedside ultrasonography performed by Intensivists. The investigators hypothesize that measurement of the carotid artery Corrected Flow Time (FTC) in response to a passive leg raise (PLR), which simulates a fluid bolus, can be used to predict fluid responsiveness.
Detailed description
Predicting fluid responsiveness in the Intensive Care Unit (ICU) is a difficult task. Clearly, early aggressive resuscitation in patients with severe sepsis and septic shock improves outcomes. Conversely, overzealous fluid administration is associated with increased mortality in patients with septic shock and acute lung injury. However, recent studies have challenged conventional wisdom that clinical exam, central venous pressure (CVP), or pulmonary artery occlusion pressure (PAOP) are able to predict volume status or fluid responsiveness.
Only approximately 50% of ICU patients have been shown to respond to volume expansion in studies designed to examine fluid responsiveness.9 Ideally, Intensivists would have access to a cheap, reliable, continuously operating, non-invasive, and user friendly device so that fluid could be administered until their patient is no longer fluid responsive. Stroke volume could be maximized via the Frank-Starling relationship and over resuscitation with its potential deleterious effects could be avoided. Although measurement of thermodilution cardiac output by the Pulmonary Artery Catheter (PAC) is considered the "gold standard" by which new devices are validated, it has a waning role in modern ICUs. Existing technologies such as Esophageal Doppler, Transpulmonary Indicator Dilution, and Arterial-Pressure-Waveform-Derived methods, while not as invasive as a PAC, are still invasive procedures. Echocardiography is an excellent tool, however assessing for fluid responsiveness requires advanced training beyond a qualitative approach and it can be difficult to obtain optimal windows in critically ill patients. Thus, current methods for assessment of fluid responsiveness are suboptimal.
The use of Carotid Doppler to determine volume responsiveness has recently been proposed. Remarkably, the authors found that an increase in carotid blood flow of 20% predicted fluid responsiveness with a sensitivity of 94% and specificity of 86%. This appears to be an attractive option, with the caveats that not all point of care ultrasound machines currently available have the software capability to calculate carotid artery velocity time integral (VTI) and this method was validated using Bioreactance, the reliability of which has been recently questioned. A more simple method of evaluating the carotid artery for fluid responsiveness, the Carotid Flow Time, was recently discussed on a popular ultrasound podcast, but has not yet been validated in a clinical study.
The Carotid Artery Corrected Flow Time (FTC) concept is not new. In fact, it has been well studied as a marker of preload and afterload with Transesophageal Doppler (TED). TED monitors display a wave form of the velocity versus time similar to the image one might obtain doing pulsed wave Doppler (PWD) of the carotid artery. With TED, the waveform has a triangular appearance. The apex of the triangle represents peak velocity, which along with mean acceleration reflects cardiac contractility. The area under the systolic portion of the curve is equal to stroke distance, and when multiplied by the cross sectional area of the descending aorta this value can be used to estimate cardiac output predicated on the assumption that the descending aorta receives 70% of cardiac output. The investigators are interested in the base of the triangle representing systolic ejection time. When corrected for heart rate by dividing by the square root of cardiac cycle time we have the FTC. The FTC would be expected to increase with enhanced preload or reduction in afterload; conversely it should decrease with a reduction in preload or increase in afterload. One study performed in 20 neurosurgical patients with TED showed that the FTC was able to predict fluid responsiveness when used as a static measure with a cutoff of 357 ms prior to loading with 7 ml/kg of hydroxyethyl starch solution. The area under the receiver operating curve (ROC) was 0.944.
The investigators believe that the concept of FTC as a marker of preload can be combined conveniently with PWD of the carotid artery and a passive leg raising maneuver (PLR) to estimate fluid responsiveness in critically ill patients. The method is very attractive due to the ease of access to the carotid artery, reproducibility, low cost, and since the FTC is a measurement of time (not velocity), the angle of insonation should be inconsequential, making the exam technically easier to perform compared to carotid artery VTI. This can be compared to a 10% increase in SVI following a PLR demonstrated by the Flotrac/Vigileo being considered the "gold standard". While the absolute values of cardiac output obtained with the Flotrac/Vigileo when compared with the PAC are debatable, the ability of the device to track changes in cardiac output/stroke volume in response to changes in preload and PLR have been shown to be accurate.16-19 A meta-analysis published by Cavallaro and colleagues showed that PLR induced changes in cardiac output were able to predict fluid responsiveness with a sensitivity and specificity of 89.4% and 91.4% with a pooled area under the ROC value of 0.95 regardless of ventilation mode, underlying cardiac rhythm, and technique of measurement. Thus, an increase in SVI > 10% with PLR detected by a Flotrac/Vigileo monitor without the need for a fluid bolus, should be sufficient to determine whether PLR induced changes in carotid FTC are able to detect fluid responsiveness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Artery Flow Time | Experimental | Other: Carotid Doppler Measurement in response to passive leg raisePatients with radial aline and flotrac vigileo will have carotid dopper measured for carotid flow time and a passive leg raise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older,
- admitted to ICU and already have an arterial line and Flotrac/Vigileo monitor in place ordered by primary team as part of their clinical standard practice.
Key exclusion criteria (7 listed)
- Not in sinus rhythm,
- clinically suspected or known intraabdominal hypertension,
- lower extremity amputee,
- femoral arterial line,
- poor or unreliable arterial line waveform,
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 |
|---|---|---|
| Carotid Doppler Measurement in response to passive leg raiseThe investigators will measure Carotid Flow time in the semi-recumbent position, then lay the patient flat and do a passive leg raise. The investigators will then meausre Carotid Flow Time at 1 minute, 2 minutes, and 3 minutes. Patients who have 10 % increase in stroke volume on the Flotrac / Vigileo monitor will be considered fluid responders. The investigators will try to identify an optimum % increase of Carotid Flow Time that can predict fluid responsiveness. | Other | Carotid Artery Flow Time |
Primary outcome
Fluid Responsiveness
Time frame: 3 minutes
Passive leg raise induced increase in stroke volume of 10% on vigileo monitor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
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Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid Doppler Measurement in response to passive leg raise in people with Fluid Responsiveness and Carotid Artery Flow Time, run by University of Louisville at 1 site in United States.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 9 Jun 2016. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid Responsiveness (time frame: 3 minutes). 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 9 Jun 2016.