ShockNCT04290767
Brain Ultrasound With Contrast Microbubbles Injection in Shock Status
A study testing Sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy) in people with Shock and Microcirculation, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Alterations in the brain microcirculation may be involved in patients with shock. For a three-day period, we investigate the brain microcirculation using contrast-enhanced ultrasound with microbubble injection in patients with septic and non-septic shock.Ultrasound examination is performed daily to estimate global… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Shock, Microcirculation
- What is being tested?
- Sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Mar 2019to 31 Dec 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Septic shock criteria: refractory arterial hypotension or hypoperfusion abnormalities after fluid resuscitation with serum lactate > 4mmmol/dl, oliguria and mental status alteration or delirium.
- Cardiogenic shock is defined as refractory shock associated with oliguria and mental status alteration following acute myocardial infarction or post-cardiac surgery.
Who cannot join
- Younger than 18 years old
- Pregnancy
- Diabetes
- Acute or chronic neurological disorder: epileptics, stroke, bleeding, trauma, post-neurosurgery, post- cardiac arrest, tumor, meningitis.
- Severe dementia, psychiatric or neuromuscular disability
- Acute coronary syndrome within one previous week
Show all 15Show fewer
- Respiratory distress ARDS with arterial oxygenation less than 70mm Hg or the FiO2 / PaO2 ratio < 200
- Advanced liver cirrhosis
- Terminal renal failure with hemodialysis and high serum uremia.> 200.
- Drug intoxications. Alcohol withdrawal.
- Advanced malign diseases
- Allergy to the microbubble contrast product Sonovue ®
- Insufficient echogenicity of bilateral temporal window to ultrasound and incomplete insonation of the intracerebral arteries
- Significant intracerebral and extracerebral arteries stenosis or severe atheromatous calcifications.
- Vertebral artery hypoplasia.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
Godelieve Opdenacker, Study nurse, 3224775117, godelieve.opdenacker@uzbrussel.be
Marie-Claire Van Malderen, Study nurse, 3324775117, marieclaire.vanmalderen@uzbrussel.be
About this study
Official title: Evaluation of the Cerebral Microcirculation by Non-invasive Brain Ultrasound With Enhanced Microbubbles Contrast Injection in Shock Status.
Alterations in the brain microcirculation may be involved in patients with shock. For a three-day period, we investigate the brain microcirculation using contrast-enhanced ultrasound with microbubble injection in patients with septic and non-septic shock.Ultrasound examination is performed daily to estimate global cerebral blood flow, and to evaluate the brain microcirculation, using variables of the time-intensity brain perfusion curve, after sulphur hexafluoride microbubble Sonovue injection.
Read the detailed description
Non-invasive brain ultrasound with transcranial echo-color doppler (IE 33, Philips Medical System, the Netherlands) is performed in three steps to 1) evaluate the global cerebral blood volume, 2) to estimate the presence or absence of cerebral autoregulation, and 3) to qualitatively evaluate the cerebral perfusion and microcirculation by enhanced microbubbles contrast injection (CEUS). Brain ultrasound is performed in the first 48 hours after hemodynamic stabilization (MAP > 65mm Hg, normotherm) and respiratory parameters stabilization (PaCO2 between 35-45mmHg and the PaO2/FiO2 > 200) after ICU admission. The second and third examination is performed in the next 48-72 hours before sedation withdrawal to limit the effect of change of cerebral hemodynamics.
Before performing brain ultrasound, echocardiography (IE 33, Philips medical System, the Netherlands) is performed to evaluate left ventricular ejection fraction and cardiac output (L/min).
First, the global cerebral blood volume (L/min) is evaluated as the sum of flow volumes of the internal carotid (ICA) and vertebral arteries (VA) extracranial arteries of both sides. The internal carotid artery (ICA) is examined with a 7-MHz linear array transducer with the head of the patient slightly titled upward, in midline position. The site of measurement is approximately 1.5cm below the carotid bulb in the in the common carotid artery (CCA) during expansion and 1.5cm away from the bifurcation in ICA. In the presence of atheromatous calcifications plaques, ICA doppler measurement is performed outside and before the plaques. The B-mode bidimensional is magnified to achieve a higher resolution and details. The internal diameter of the vessel is measured at the exact site of the pulse doppler velocity measurement ample volume, between both endothelial layers, perpendicular of the course of the vessel. The diameter of the vertebral artery is examined and magnified in B-mode. The transducer is positioned along the CCA, shiftily laterally and angled until the intertransverse segment of the VA is seen and the doppler velocity is measured at the C4-C5 transverse area along the common carotid artery exactly at the same place of diameter measurement. The following measurements of flow velocities are taken in each artery: Peak systolic and end-diastolic velocity, time-averaged velocity (TAV), Pulsatility Index (PI). Flow volume (Q) of each artery is determined as Q = TAV x Area ((diameter of the artery /2)² x PI).
Transcranial echo-color doppler is performed via temporal windows and the Pulsatility Index (PI) and the mean flow velocities (cm/sec) are measured of MCA, at both sides are recorded. Cerebrovascular resistance index as defined as the ration MAP/Mean Flow velocity of MCA (mmHg/cm per second).
Second, after measuring the global cerebral blood volume, the presence or absence of cerebral autoregulation (CA) is tested with the Transient hyperemic response (THR) by measuring the velocity of the media cerebral artery (MCA) the following an ipsilateral common carotid compression during 8 seconds. THR is defined as the F3/F1 ratio F1 as the MCA velocity before compression and F3 is the second MCA velocity after compression test). THR test is valid when onset of compression results a sudden and maximal decrease in MCA blood velocity and remains stable during compression.
Third, after testing the THR, the brain regional microcirculation is evaluated by the microbubbles contrast injection SONOVUE (Italy) following the European guidelines recommendation for contrast microbubbles enhanced ultrasound. The brain parenchyma is insonated via the temporal bone windows at the depth of 10cm with the ultrasound S5 multifrequency transducer 2-5 MHz probe. After optimizing the acoustic bone window, SONOVUE is injected intravenously as a bolus 2.4ml followed by 10ml saline flushed. The contralateral brain is evaluated 5 minutes after the first injection of SONOVUE to allow a complete evacuation of contrast microbubbles.
All real-time CEUS images were stored digitally on the hard disk as DICOM (Digital Image Communications in Medicine) images. Offline analysis used the QLAB 10 quantification software (Philips Medical System, the Netherlands) to convert brain perfusion images into time-intensity curves (TIC) corresponding to the five different regions of interest (ROI) of brain parenchyma: anterior and posterior thalamus, lentiform nucleus, parieto-temporal and posterior white matter. Four variables were extracted from these TIC curves to qualitatively evaluate the brain microcirculation: peak intensity in dB (PI), time to peak intensity in seconds (TTP), mean transit time in seconds (MTT), and area under the curve in dB/seconds (AUC) .
- Conditions
- Shock, Microcirculation
- Being tested
- Sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy)
- Keywords
- Shock, Brain microcirculattion, Enhanced-contrast brain ultrasound, Sulphur hexafluoride microbubbles contrast Sonovue
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy)Diagnostic test
Enhanced-contrast brain ultrasound with intravenously sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy) injection and using the time-intensity curve profile to evaluate brain microcirculation.
| Study group | Role | What they receive |
|---|---|---|
| Sonovue | Other | ICU patients with acute shock status (septic or non-septic) who are eligible for enhanced-contrast brain ultrasound with sulphur hexafluoride microbubbles contrast (Sonovue, BRACCO, Milan, Italy) examination. Receives: Diagnostic Test: Sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative evaluation of the brain microcirculation using Sonovue injection: Mean transit time (seconds) of the time intensity curve - Mean change from baseline
Ultrasound examination is performed daily to evaluate the brain microcirculation, using variables of the time-intensity brain perfusion curve, after Sonovue microbubble injection. We hypothesize that the mean transit time (seconds) of this curve is early prolonged in ICU non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Qualitative evaluation of the brain microcirculation using Sonovue injection: Peak Intensity (dB) of the time intensity curve - Mean change from baseline
Ultrasound examination is performed daily to evaluate the brain microcirculation, using variables of the time-intensity brain perfusion curve, after Sonovue microbubble injection. We hypothesize that the peak intensity (dB) of this curve is early reduced in ICU non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Qualitative evaluation of the brain microcirculation using Sonovue injection: Are under the curve (percentage) of the time intensity curve - Mean change from baseline
Ultrasound examination is performed daily to evaluate the brain microcirculation, using variables of the time-intensity brain perfusion curve, after Sonovue microbubble injection. We hypothesize that the area under the curve (percentage) of this curve is early reduced in ICU non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Testing daily cerebral autoregulation: Transient Hyperemic response test - Absence or presence from baseline
The presence or absence of cerebral autoregulation is assessed using the transient hyperemic response (THR) test, which measures the change in flow velocity in the MCA following a mild 5-second compression of the ipsilateral common carotid artery (CCA) using brain ultrasound. Cerebral autoregulation is considered absent if the flow velocity in the MCA after the compression of the ipsilateral CCA is released do not increase by more than 10% compared to the value prior to compression.
We hypothesize that cerebral autoregulation is absent in ICU non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Qualitative evaluation of the brain microcirculation: Mean velocity of the middle cerebral artery (cm/second) - Mean change from baseline
Brain ultrasound is daily performed to measure the mean velocity of both middle cerebral arteries. We hypothesize that these velocities remain unchanged or even increased in ICU non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Secondary outcomes (2)
Qualitative evaluation of the brain microcirculation: Cardiac output (L/minute) - Mean change from baseline
Daily transthoracic echocardiography is performed to measure the aortic velocity time integral (cm) to estimate cardiac output.
We hypothesize that cardiac output is unchanged or even increased in ICU non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Qualitative evaluation of the brain microcirculation: Global cerebral blood flow (L/minute) - Mean change from baseline
Daily duplex echo-color of the carotids and vertebral arteries is performed to estimate global cerebral blood flow (L/minute) - Mean change from baseline.
We hypothesize that global cerebral blood flow is unchanged or even increased in ICU non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start6 Mar 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Cohort study in a single center
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duc Nam Nguyen, Universitair Ziekenhuis Brussel
- Investigators
- Duc Nam Nguyen, MD, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290767
- Sponsor's protocol ID
- B.U.N. 143201421588
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piscaglia F, Nolsoe C, Dietrich CF, Cosgrove DO, Gilja OH, Bachmann Nielsen M, Albrecht T, Barozzi L, Bertolotto M, Catalano O, Claudon M, Clevert DA, Correas JM, D'Onofrio M, Drudi FM, Eyding J, Giovannini M, Hocke M, Ignee A, Jung EM, Klauser AS, Lassau N, Leen E, Mathis G, Saftoiu A, Seidel G, Sidhu PS, ter Haar G, Timmerman D, Weskott HP. The EFSUMB Guidelines and Recommendations on the Clinical Practice of Contrast Enhanced Ultrasound (CEUS): update 2011 on non-hepatic applications. Ultraschall Med. 2012 Feb;33(1):33-59. doi: 10.1055/s-0031-1281676. Epub 2011 Aug 26. No abstract available.
PubMed 21874631Powers J, Averkiou M, Bruce M. Principles of cerebral ultrasound contrast imaging. Cerebrovasc Dis. 2009;27 Suppl 2:14-24. doi: 10.1159/000203123. Epub 2009 Apr 16.
PubMed 19372657Seidel G, Meairs S. Ultrasound contrast agents in ischemic stroke. Cerebrovasc Dis. 2009;27 Suppl 2:25-39. doi: 10.1159/000203124. Epub 2009 Apr 16.
PubMed 19372658Wiesmann M, Seidel G. Ultrasound perfusion imaging of the human brain. Stroke. 2000 Oct;31(10):2421-5. doi: 10.1161/01.str.31.10.2421.
PubMed 11022074
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cerebral Microcirculation by Non-invasive Brain Ultrasound With Enhanced Microbubbles Contrast Injection in Shock Status.
- ClinicalTrials.gov ID
- NCT04290767
- Acronym / sponsor ID
- B.U.N. 143201421588
- Conditions
- Shock, Microcirculation
- Keywords
- Shock, Brain microcirculattion, Enhanced-contrast brain ultrasound, Sulphur hexafluoride microbubbles contrast Sonovue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Mar 2020 (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.
Alterations in the brain microcirculation may be involved in patients with shock. For a three-day period, we investigate the brain microcirculation using contrast-enhanced ultrasound with microbubble injection in patients with septic and non-septic shock.Ultrasound examination is performed daily to estimate global cerebral blood flow, and to evaluate the brain microcirculation, using variables of the time-intensity brain perfusion curve, after sulphur hexafluoride microbubble Sonovue injection.
Detailed description
Non-invasive brain ultrasound with transcranial echo-color doppler (IE 33, Philips Medical System, the Netherlands) is performed in three steps to 1) evaluate the global cerebral blood volume, 2) to estimate the presence or absence of cerebral autoregulation, and 3) to qualitatively evaluate the cerebral perfusion and microcirculation by enhanced microbubbles contrast injection (CEUS). Brain ultrasound is performed in the first 48 hours after hemodynamic stabilization (MAP > 65mm Hg, normotherm) and respiratory parameters stabilization (PaCO2 between 35-45mmHg and the PaO2/FiO2 > 200) after ICU admission. The second and third examination is performed in the next 48-72 hours before sedation withdrawal to limit the effect of change of cerebral hemodynamics.
Before performing brain ultrasound, echocardiography (IE 33, Philips medical System, the Netherlands) is performed to evaluate left ventricular ejection fraction and cardiac output (L/min).
First, the global cerebral blood volume (L/min) is evaluated as the sum of flow volumes of the internal carotid (ICA) and vertebral arteries (VA) extracranial arteries of both sides. The internal carotid artery (ICA) is examined with a 7-MHz linear array transducer with the head of the patient slightly titled upward, in midline position. The site of measurement is approximately 1.5cm below the carotid bulb in the in the common carotid artery (CCA) during expansion and 1.5cm away from the bifurcation in ICA. In the presence of atheromatous calcifications plaques, ICA doppler measurement is performed outside and before the plaques. The B-mode bidimensional is magnified to achieve a higher resolution and details. The internal diameter of the vessel is measured at the exact site of the pulse doppler velocity measurement ample volume, between both endothelial layers, perpendicular of the course of the vessel. The diameter of the vertebral artery is examined and magnified in B-mode. The transducer is positioned along the CCA, shiftily laterally and angled until the intertransverse segment of the VA is seen and the doppler velocity is measured at the C4-C5 transverse area along the common carotid artery exactly at the same place of diameter measurement. The following measurements of flow velocities are taken in each artery: Peak systolic and end-diastolic velocity, time-averaged velocity (TAV), Pulsatility Index (PI). Flow volume (Q) of each artery is determined as Q = TAV x Area ((diameter of the artery /2)² x PI).
Transcranial echo-color doppler is performed via temporal windows and the Pulsatility Index (PI) and the mean flow velocities (cm/sec) are measured of MCA, at both sides are recorded. Cerebrovascular resistance index as defined as the ration MAP/Mean Flow velocity of MCA (mmHg/cm per second).
Second, after measuring the global cerebral blood volume, the presence or absence of cerebral autoregulation (CA) is tested with the Transient hyperemic response (THR) by measuring the velocity of the media cerebral artery (MCA) the following an ipsilateral common carotid compression during 8 seconds. THR is defined as the F3/F1 ratio F1 as the MCA velocity before compression and F3 is the second MCA velocity after compression test). THR test is valid when onset of compression results a sudden and maximal decrease in MCA blood velocity and remains stable during compression.
Third, after testing the THR, the brain regional microcirculation is evaluated by the microbubbles contrast injection SONOVUE (Italy) following the European guidelines recommendation for contrast microbubbles enhanced ultrasound. The brain parenchyma is insonated via the temporal bone windows at the depth of 10cm with the ultrasound S5 multifrequency transducer 2-5 MHz probe. After optimizing the acoustic bone window, SONOVUE is injected intravenously as a bolus 2.4ml followed by 10ml saline flushed. The contralateral brain is evaluated 5 minutes after the first injection of SONOVUE to allow a complete evacuation of contrast microbubbles.
All real-time CEUS images were stored digitally on the hard disk as DICOM (Digital Image Communications in Medicine) images. Offline analysis used the QLAB 10 quantification software (Philips Medical System, the Netherlands) to convert brain perfusion images into time-intensity curves (TIC) corresponding to the five different regions of interest (ROI) of brain parenchyma: anterior and posterior thalamus, lentiform nucleus, parieto-temporal and posterior white matter. Four variables were extracted from these TIC curves to qualitatively evaluate the brain microcirculation: peak intensity in dB (PI), time to peak intensity in seconds (TTP), mean transit time in seconds (MTT), and area under the curve in dB/seconds (AUC) .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort study in a single center
| Arm | Type | Receives |
|---|---|---|
| Sonovue | Other | Diagnostic Test: Sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy)ICU patients with acute shock status (septic or non-septic) who are eligible for enhanced-contrast brain ultrasound with sulphur hexafluoride microbubbles contrast (Sonovue, BRACCO, Milan, Italy) examination. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Septic shock criteria: refractory arterial hypotension or hypoperfusion abnormalities after fluid resuscitation with serum lactate > 4mmmol/dl, oliguria and mental status alteration or delirium.
- Cardiogenic shock is defined as refractory shock associated with oliguria and mental status alteration following acute myocardial infarction or post-cardiac surgery.
Key exclusion criteria (15 listed)
- Younger than 18 years old
- Pregnancy
- Diabetes
- Acute or chronic neurological disorder: epileptics, stroke, bleeding, trauma, post-neurosurgery, post- cardiac arrest, tumor, meningitis.
- Severe dementia, psychiatric or neuromuscular disability
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 |
|---|---|---|
| Sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy)Enhanced-contrast brain ultrasound with intravenously sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy) injection and using the time-intensity curve profile to evaluate brain microcirculation. | Diagnostic test | Sonovue |
Primary outcome
Qualitative evaluation of the brain microcirculation using Sonovue injection: Mean transit time (seconds) of the time intensity curve - Mean change from baseline
Time frame: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Ultrasound examination is performed daily to evaluate the brain microcirculation, using variables of the time-intensity brain perfusion curve, after Sonovue microbubble injection. We hypothesize that the mean transit time (seconds) of this curve is early prolonged in ICU non-survivors.
Qualitative evaluation of the brain microcirculation using Sonovue injection: Peak Intensity (dB) of the time intensity curve - Mean change from baseline
Time frame: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Ultrasound examination is performed daily to evaluate the brain microcirculation, using variables of the time-intensity brain perfusion curve, after Sonovue microbubble injection. We hypothesize that the peak intensity (dB) of this curve is early reduced in ICU non-survivors.
Qualitative evaluation of the brain microcirculation using Sonovue injection: Are under the curve (percentage) of the time intensity curve - Mean change from baseline
Time frame: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Ultrasound examination is performed daily to evaluate the brain microcirculation, using variables of the time-intensity brain perfusion curve, after Sonovue microbubble injection. We hypothesize that the area under the curve (percentage) of this curve is early reduced in ICU non-survivors.
Testing daily cerebral autoregulation: Transient Hyperemic response test - Absence or presence from baseline
Time frame: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
The presence or absence of cerebral autoregulation is assessed using the transient hyperemic response (THR) test, which measures the change in flow velocity in the MCA following a mild 5-second compression of the ipsilateral common carotid artery (CCA) using brain ultrasound. Cerebral autoregulation is considered absent if the flow velocity in the MCA after the compression of the ipsilateral CCA is released do not increase by more than 10% compared to the value prior to compression. We hypothesize that cerebral autoregulation is absent in ICU non-survivors.
Qualitative evaluation of the brain microcirculation: Mean velocity of the middle cerebral artery (cm/second) - Mean change from baseline
Time frame: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Brain ultrasound is daily performed to measure the mean velocity of both middle cerebral arteries. We hypothesize that these velocities remain unchanged or even increased in ICU non-survivors.
2 secondary outcomes
Qualitative evaluation of the brain microcirculation: Cardiac output (L/minute) - Mean change from baseline
Time frame: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Qualitative evaluation of the brain microcirculation: Global cerebral blood flow (L/minute) - Mean change from baseline
Time frame: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Background: PubMed 21874631Piscaglia F, Nolsoe C, Dietrich CF, Cosgrove DO, Gilja OH, Bachmann Nielsen M, Albrecht T, Barozzi L, Bertolotto M, Catalano O, Claudon M, Clevert DA, Correas JM, D'Onofrio M, Drudi FM, Eyding J, Giovannini M, Hocke M, Ignee A, Jung EM, Klauser AS, Lassau N, Leen E, Mathis G, Saftoiu A, Seidel G, Sidhu PS, ter Haar G, Timmerman D, Weskott HP. The EFSUMB Guidelines and Recommendations on the Clinical Practice of Contrast Enhanced Ultrasound (CEUS): update 2011 on non-hepatic applications. Ultraschall Med. 2012 Feb;33(1):33-59. doi: 10.1055/s-0031-1281676. Epub 2011 Aug 26. No abstract available.
- Background: PubMed 19372657Powers J, Averkiou M, Bruce M. Principles of cerebral ultrasound contrast imaging. Cerebrovasc Dis. 2009;27 Suppl 2:14-24. doi: 10.1159/000203123. Epub 2009 Apr 16.
- Background: PubMed 19372658Seidel G, Meairs S. Ultrasound contrast agents in ischemic stroke. Cerebrovasc Dis. 2009;27 Suppl 2:25-39. doi: 10.1159/000203124. Epub 2009 Apr 16.
- Background: PubMed 11022074Wiesmann M, Seidel G. Ultrasound perfusion imaging of the human brain. Stroke. 2000 Oct;31(10):2421-5. doi: 10.1161/01.str.31.10.2421.
- Individual participant dataSharing planned: No
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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.
Duc Nam Nguyen, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy) in people with Shock and Microcirculation, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 15 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: status not confirmed, as of the sponsor's last update on 2 Mar 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duc Nam Nguyen, MD, PhD (3224775178, namduc.nguyen@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative evaluation of the brain microcirculation using Sonovue injection: Mean transit time (seconds) of the time intensity curve - Mean change from baseline (time frame: Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04290767, which also lists 4 linked publications.
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 2 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.