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WithdrawnNCT03412422Updated Jan 23, 2020

Ultrasound Assessment of Changes in the Diameter of the Common Carotid Artery After Increasing the Preload of the Heart

An observational study in Critical Illness and Fluid Responsiveness, sponsored by Uniwersytecki Szpital Kliniczny w Opolu. Withdrawn at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by Uniwersytecki Szpital Kliniczny w Opolu · Observational

Why this study was withdrawn
The study has been stopped due to technical difficulties.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study summary

Passive leg raise (PLR) and fluid challenge are useful tools in assessing the fluid responsiveness. However, they require continuous monitoring of cardiac output, which is usually an invasive technique and in some cases not always available. Vascular ultrasound can be an alternative to cardiac output monitoring in a fluid status evaluation. The common carotid artery (CCA) is an easily accessible vessel. It has recently been noted that the diameter of this artery changes after an intravenous fluid bolus. It is possible that the change in the diameter of the common carotid artery during passive leg raise and fluid challenge can be a predictor of fluid responsiveness.

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Conditions studied

  • Critical Illness
  • Fluid Responsiveness

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Keywords

  • Passive Leg Raise
  • Fluid Challenge
  • Common carotid artery
03

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

Browse Critical Illness studies →

Lead sponsor

Uniwersytecki Szpital Kliniczny w Opolu is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Mechanically ventilated patients admitted to critical care unit.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • mechanically ventilated patients with circulatory failure, who are monitored with PiCCO and need fluid responsiveness assessment

Exclusion criteria

Exclusion Criteria:

  • for the volume administration (hydrostatic pulmonary edema or other evidence of fluid overload)
  • contraindication for PLR test (e.g. after trauma)
  • lack of possibility to examine the carotid arteries
  • bilateral carotid surgery in the past
  • bilateral anatomical defects of the carotid arteries
  • unstable cardiac rhythm (e.g. atrial fibrillation)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Acute circulatory failure

    Mechanically ventilated patients with acute circulatory failure, monitored with PiCCO method, who need fluid responsiveness assessment.

    Diagnostic Test: fluid responsiveness assessment

Interventions

  • Diagnostic testfluid responsiveness assessment

    During the procedure, the investigator will be imaging one of the carotid arteries with ultrasound. In expiratory phase, four sets of three video loops will be recorded: before and after PLR and then before and after fluid challenge. There also will be noted hemodynamic parameters measured with PiCCO monitor. The fluid challenge is defined as administration of 500ml of crystalloid in less than 10 minutes. Later, another investigator, who will be blinded to other data, will measure the maximal and minimal diameter of CCA in each loop. The measurements will be averaged and eventually two values (maximal an minimal) from each set will be obtained.

    Also known as: passive leg raise, fluid challenge

06

What researchers measure

Primary outcomes

  1. Changes in the diameter of the common carotid artery

    The diameter will be measured with ultrasound

    Time frame: 1 minute after PLR test and 1 minute after fluid challenge

Secondary outcomes

  1. Evaluation the value of changes in the diameter of CCA as the predictor of fluid responsiveness.

    The changes in the diameter of CCA will be compared with the changes in cardiac output measured with PiCCO method.

    Time frame: 1 minute after PLR test and 1 minute after fluid challenge

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Study locations

1 site
  • Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
    Opole, Opolskie 45-372, Poland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2019; primary completion for Oct 2020, 16 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2018
First posted
Jan 26, 2018
StartEst.
Jun 1, 2019
Primary completionEst.
Oct 1, 2020
CompletionEst.
Oct 1, 2020
Last update
Jan 23, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03412422
Lead sponsor
Uniwersytecki Szpital Kliniczny w Opolu
Responsible party
Maciej Piwoda (Principal Investigator, Uniwersytecki Szpital Kliniczny w Opolu) — Principal investigator
First posted
Jan 26, 2018
Start date
Jun 1, 2019 (estimated)
Primary completion
Oct 1, 2020 (estimated)
Completion
Oct 1, 2020 (estimated)
Last update
Jan 23, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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