Critical IllnessNCT03412422
Ultrasound Assessment of Changes in the Diameter of the Common Carotid Artery After Increasing the Preload of the Heart
An observational study of Critical Illness and Fluid Responsiveness, run by Uniwersytecki Szpital Kliniczny w Opolu at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Fluid Responsiveness
- What is being tested?
- fluid responsiveness assessment
- How many people
- 0 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2019to 1 Oct 2020
- Phase
- Observational
- 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
Study population: Mechanically ventilated patients admitted to critical care unit.
Who may be able to join
- mechanically ventilated patients with circulatory failure, who are monitored with PiCCO and need fluid responsiveness assessment
Who cannot join
- contraindication 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)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
Opole, Opole Voivodeship, 45-372
About this study
Official title: Ultrasound Assessment of Changes in the Diameter of the Common Carotid Artery After Increasing the Preload of the Heart With Passive Leg Raise and Intravenous Fluid Infusion
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.
- Conditions
- Critical Illness, Fluid Responsiveness
- Being tested
- fluid responsiveness assessment
- Keywords
- Passive Leg Raise, Fluid Challenge, Common carotid artery
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid responsiveness assessmentDiagnostic test
Also called passive leg raise, fluid challenge
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute circulatory failure | Mechanically ventilated patients with acute circulatory failure, monitored with PiCCO method, who need fluid responsiveness assessment. Receives: Diagnostic Test: fluid responsiveness assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the diameter of the common carotid artery
The diameter will be measured with ultrasound
Measured: 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.
Measured: 1 minute after PLR test and 1 minute after fluid challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Jun 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Why it stopped: The study has been stopped due to technical difficulties.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w Opolu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej Piwoda, Uniwersytecki Szpital Kliniczny w Opolu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412422
- Sponsor's protocol ID
- CCA_USG_PLR_USK
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Changes in the Diameter of the Common Carotid Artery After Increasing the Preload of the Heart With Passive Leg Raise and Intravenous Fluid Infusion
- ClinicalTrials.gov ID
- NCT03412422
- Acronym / sponsor ID
- CCA_USG_PLR_USK
- Conditions
- Critical Illness, Fluid Responsiveness
- Keywords
- Passive Leg Raise, Fluid Challenge, Common carotid artery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study has been stopped due to technical difficulties.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w OpoluUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 26 Jan 2018 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute circulatory failure | – | Diagnostic Test: fluid responsiveness assessmentMechanically ventilated patients with acute circulatory failure, monitored with PiCCO method, who need fluid responsiveness assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients admitted to critical care unit.
Key inclusion criteria (1 listed)
- mechanically ventilated patients with circulatory failure, who are monitored with PiCCO and need fluid responsiveness assessment
Key exclusion criteria (6 listed)
- contraindication 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
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 |
|---|---|---|
| fluid responsiveness assessmentAlso: passive leg raise, fluid challengeDuring 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. | Diagnostic test | Acute circulatory failure |
Primary outcome
Changes in the diameter of the common carotid artery
Time frame: 1 minute after PLR test and 1 minute after fluid challenge
The diameter will be measured with ultrasound
1 secondary outcome
Evaluation the value of changes in the diameter of CCA as the predictor of fluid responsiveness.
Time frame: 1 minute after PLR test and 1 minute after fluid challenge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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?
An observational study of Critical Illness and Fluid Responsiveness, run by Uniwersytecki Szpital Kliniczny w Opolu at 1 site in Poland.
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 1 inclusion and 6 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: withdrawn, as of the sponsor's last update on 23 Jan 2020. 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 Poland. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in the diameter of the common carotid artery (time frame: 1 minute after PLR test and 1 minute after fluid challenge). 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 2020.