AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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.

United States1 site
  • University of Louisville

    Louisville, Kentucky

Other trials in United States

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 groups in NCT02789124
Study groupRoleWhat they receive
Carotid Artery Flow TimeExperimentalPatients 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.

  1. 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.

  1. First posted2 Jun 2016 (estimated)
  2. Study startJun 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in