AnesthesiaNCT03713008
Assessment Of Carotid Flow During General Anesthesia
A study testing Fluid bolus in people with Anesthesia and Fluid Responsiveness, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Proper identification of patients who would benefit from fluid infusion (fluid responsiveness) is one of the most crucial challenges in anaesthesia and critical care. Reliability of several invasive measurements used for this purpose for many years have been questioned recently. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, Fluid Responsiveness
- What is being tested?
- Fluid bolus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 sitePoland
- Study dates
- 22 Oct 2018to 30 Mar 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major abdominal surgery
- Artery catheter required
Who cannot join
- Laparoscopic surgery
- Known history of carotid endarterectomy
- Known history of carotid stenosis
- Non-sinus rhythm
- Systolic or diastolic heart failure
- Chronic kidney disease
Show all 10Show fewer
- Pulmonary hypertension
- Carotid artery anomaly
- Unable to visualise carotid artery
- Angle of correction > 60
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Fluid Responsiveness With Carotid Flow Change During General Anaesthesia
Proper identification of patients who would benefit from fluid infusion (fluid responsiveness) is one of the most crucial challenges in anaesthesia and critical care. Reliability of several invasive measurements used for this purpose for many years have been questioned recently. The study will evaluate consistency between carotid artery flow derivatives and standard haemodynamic measurement (LIDCO rapid) in navigation of intraoperative fluid therapy.
- Conditions
- Anesthesia, Fluid Responsiveness
- Being tested
- Fluid bolus
- Keywords
- Fluid Responsiveness, Anesthesia, Surgery, Stroke Volume Variation, Fluid status,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid bolusDiagnostic test
All patients included in the study will receive 5 ml/kg fluid bolus of a balanced crystalloid solution.
| Study group | Role | What they receive |
|---|---|---|
| Fluid bolus | Experimental | Patients included in the study will receive fluid bolus. Receives: Diagnostic Test: Fluid bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac output
A measure of change of scaled cardiac output (nCO) with LiDCO device
Measured: Before and 2 minutes after intervention
Change in a corrected carotid artery flow
Ultrasound measure of corrected carotid artery flow time
Measured: Before and 2 minutes after intervention
Secondary outcomes (5)
Change in pulse pressure variation
A measure of change of pulse pressure variation (PPV) with LiDCO device
Measured: Before and 2 minutes after intervention
Change in stroke volume variation
A measure of change of pulse pressure variation with LiDCO device
Measured: Before and 2 minutes after intervention
Change in a carotid blood flow
Ultrasound measure of corrected carotid blood flow time
Measured: Before and 2 minutes after intervention
Change in a velocity time integral of carotid flow
Ultrasound measure of velocity time integral of carotid flow
Measured: Before and 2 minutes after intervention
Change in the maximal systolic carotid velocity variation
Ultrasound measure of the maximal systolic carotid velocity variation
Measured: Before and 2 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start22 Oct 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Model description
- All patients included in the study will receive 4 ml/kg fluid bolus.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713008
- Sponsor's protocol ID
- CART
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2018
- Last updated
- 11 Oct 2019
- 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 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fluid Responsiveness With Carotid Flow Change During General Anaesthesia
- ClinicalTrials.gov ID
- NCT03713008
- Acronym / sponsor ID
- CART
- Conditions
- Anesthesia, Fluid Responsiveness
- Keywords
- Fluid Responsiveness, Anesthesia, Surgery, Stroke Volume Variation, Fluid status,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 19 Oct 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.
Proper identification of patients who would benefit from fluid infusion (fluid responsiveness) is one of the most crucial challenges in anaesthesia and critical care. Reliability of several invasive measurements used for this purpose for many years have been questioned recently. The study will evaluate consistency between carotid artery flow derivatives and standard haemodynamic measurement (LIDCO rapid) in navigation of intraoperative fluid therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients included in the study will receive 4 ml/kg fluid bolus.
| Arm | Type | Receives |
|---|---|---|
| Fluid bolus | Experimental | Diagnostic Test: Fluid bolusPatients included in the study will receive fluid bolus. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major abdominal surgery
- Artery catheter required
Key exclusion criteria (10 listed)
- Laparoscopic surgery
- Known history of carotid endarterectomy
- Known history of carotid stenosis
- Non-sinus rhythm
- Systolic or diastolic heart failure
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 bolusAll patients included in the study will receive 5 ml/kg fluid bolus of a balanced crystalloid solution. | Diagnostic test | Fluid bolus |
Primary outcome
Change in cardiac output
Time frame: Before and 2 minutes after intervention
A measure of change of scaled cardiac output (nCO) with LiDCO device
Change in a corrected carotid artery flow
Time frame: Before and 2 minutes after intervention
Ultrasound measure of corrected carotid artery flow time
5 secondary outcomes
Change in pulse pressure variation
Time frame: Before and 2 minutes after intervention
Change in stroke volume variation
Time frame: Before and 2 minutes after intervention
Change in a carotid blood flow
Time frame: Before and 2 minutes after intervention
Change in a velocity time integral of carotid flow
Time frame: Before and 2 minutes after intervention
Change in the maximal systolic carotid velocity variation
Time frame: Before and 2 minutes after intervention
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 11 Oct 2019.
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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 Fluid bolus in people with Anesthesia and Fluid Responsiveness, run by Medical University of Warsaw 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 2 inclusion and 10 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 11 Oct 2019. 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 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?
Change in cardiac output (time frame: Before and 2 minutes after intervention). The study lists 2 primary outcomes in all. 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 11 Oct 2019.