Cardiorespiratory ArrestNCT04294316
Enhanced-contrast Brain Ultrasound in Cardiorespiratory Arrest
A study testing Sonovue in people with Cardiorespiratory Arrest and Microcirculation, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Brain microcirculation alterations may be involved in comatose patients and non-survivors after cardiorespiratory arrest. For a three day-period, we investigate brain microcirculation using contrast-enhanced ultrasound with contrast Sonovue injection in patients with successful resuscitation after out-hospital or… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiorespiratory Arrest, Microcirculation
- What is being tested?
- Sonovue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 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
- ICU patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest
Who cannot join
- Younger than 18 years old
- Pregnancy
- Acute or history of neurological disorder: stroke, bleeding, trauma, post-neurosurgery, tumor, meningitis.
- Severe dementia, psychiatric or neuromuscular disability
- Untreated Acute coronary syndrome
- Acute Respiratory Distress Syndrome (ARDS) with the ratio of arterial oxygen partial pressure (mmHg) to fractional inspired oxygen (PaO2/ FiO2) less than 150
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- Severe systolic pulmonary hypertension above 90 mmHg
- Advanced liver cirrhosis with hyperammonemia
- Uremia > 200mmol/L
- Acute drug intoxications with coma
- Acute alcohol intoxication or withdrawal syndrome.
- Advanced malign diseases.
- History of allergy to the microbubble contrast SONOVUE.
- Insufficient echogenicity to ultrasound and incomplete insonation of the intracerebral arteries and brain parenchyma.
- Significant intracerebral and extracerebral arteries stenosis (≥ 70%) or vertebral artery hypoplasia (3mm).
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair ziekenhuis Brussel
Brussels, 1200
Marie-Claire Van Malderen, Stidy nurse, 003224775117, marieclaire.vanmalderen@uzbrussel.be
Godelieve Opdenacker, Study nurse, 003224775117, godelieve.opdenacker@uzbrussel.be
About this study
Official title: Evaluation of Cerebral Microcirculation Using Non-invasive Contrast-enhanced Ultrasound and Microbubbles Sonovue Administration After Clinical Cardiorespiratory Arrest
Brain microcirculation alterations may be involved in comatose patients and non-survivors after cardiorespiratory arrest. For a three day-period, we investigate brain microcirculation using contrast-enhanced ultrasound with contrast Sonovue injection in patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest.
Read the detailed description
Brain ultrasound, extracranial echo-color duplex and ocular ultrasound (IE 33, Philips Medical System, the Netherlands) are performed in the first 24 hours, at 48 hours, and at 72-96 hours after successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest.
Ultrasound examinations are performed in four 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 4) to qualitatively evaluate the intracranial pressure.
Before performing brain ultrasound, echocardiography (IE 33, Philips medical System, the Netherlands) is performed to evaluate the 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 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).
Brain ultrasound is performed via temporal windows to measure the mean flow velocities (cm/sec) of the middle cerebral arteries.
Second, the presence or absence of cerebral autoregulation is tested with the Transient hyperemic response by an ipsilateral common carotid compression one side and another during 5 seconds. Absence of cerebral autoregulation is considered if the flow velocity of the middle cerebral artery do not increase more than 10% after the compression.
Third, the brain regional microcirculation is evaluated by the microbubbles contrast injection of Sonovue. The brain parenchyma is insonated via the temporal bone windows at the depth of 10cm with the ultrasound S5 multifrequency transducer 2-5 Megahertz (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 images are stored digitally on the hard disk as DICOM (Digital Image Communications in Medicine) images. Offline imaging analysis using a specific quantification software named QLAB10 (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, time to peak intensity in seconds, mean transit time in seconds (MTT), and area under the curve in percentage (AUC).
To qualitatively evaluate the intracranial pressure, ocular ultrasound is performed to measure the change of the optic nerve sheath diameter(mm). Elevation of intracranial pressure is considered if this diameter is above 0.55 mm
- Conditions
- Cardiorespiratory Arrest, Microcirculation
- Being tested
- Sonovue
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonovueDiagnostic test
Twice dose of 2.4ml of Sulphur hexafluoride microbubbles contrast Sonovue administration to evaluate brain microcirculation
| Study group | Role | What they receive |
|---|---|---|
| Sonovue group | Other | ICU patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest who are eligible for enhanced-contrast brain ultrasound, extracranial echo-color duplex, and ocular ultrasound. Receives: Diagnostic Test: Sonovue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of the Mean transit time from baseline (seconds)
Qualitative evaluation of brain microcirculation using the variables of the time-intensity curve after Sonovue administration: a prolonged of Mean transit time is expected in comatose patients or non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Mean change of the Peak intensity from baseline (dB).
Qualitative evaluation of brain microcirculation using the variables of the time-intensity curve after Sonovue administration: a reduction of Peak intensity is expected in comatose patients or non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Mean change of the time to Peak intensity from baseline (seconds).
Qualitative evaluation of brain microcirculation using the variables of the time-intensity curve after Sonovue administration: a reduction of the time to peak intensity is expected in comatose patients or non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Mean change of the Area under the curve from baseline (percentage).
Qualitative evaluation of brain microcirculation using the variables of the time-intensity curve after Sonovue administration: a reduction of the area under the curve is expected in comatose patients or non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Testing cerebral autoregulation: Transient Hyperemic test- Absence or presence from baseline
Absence of cerebral autoregulation is considered if there is no change in flow velocities of the middle cerebral arteries after short compression of the common carotid arteries occur comparing with the value prior to compression.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Mean change of the optic nerve sheath diameter from baseline (mm)
Qualitative estimation of intracranial pressure using ocular ultrasound to measure the optic nerve sheath diameter. Elevation of intracranial pressure with increase of this diameter above 0.55 mm is expected in comatose patients or non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Secondary outcomes (3)
Mean change of the mean velocities of the middle cerebral arteries from baseline (cm/second)
Qualitative evaluation of brain macrocirculation using brain ultrasound to measure the velocities of the middle cerebral arteries. Unchanged or elevation of these velocities are expected in comatose patients or non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Mean change of global cerebral blood flow from baseline (L/minute)
Qualitative evaluation of brain macrocirculation: using extracranial echo-color duplex to measure the velocities of both carotid and vertebral arteries to estimate global cerebral blood flow. Unchanged or elevation of cerebral blood flow is expected in comatose patients or non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Mean change of cardiac output from baseline (L/minute)
Qualitative evaluation of brain macrocirculation: using transthoracic echocardiography to estimate cardiac output. Unchanged or elevation of cardiac output is expected in comatose patients or non-survivors.
Measured: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 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 posted4 Mar 2020
- Study start1 Nov 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 (5)Papers the sponsor has linked to this study.
- Other trials for Cardiorespiratory ArrestStudies 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
- ICU patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest who are eligible for enhanced-contrast brain ultrasound with sulphur hexafluoride microbubbles contrast Sonovue examination
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT04294316
- Sponsor's protocol ID
- B.U.N 143201941163
- Status last verified
- Feb 2020
- First submitted
- 29 Feb 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robba C, Goffi A, Geeraerts T, Cardim D, Via G, Czosnyka M, Park S, Sarwal A, Padayachy L, Rasulo F, Citerio G. Brain ultrasonography: methodology, basic and advanced principles and clinical applications. A narrative review. Intensive Care Med. 2019 Jul;45(7):913-927. doi: 10.1007/s00134-019-05610-4. Epub 2019 Apr 25.
PubMed 31025061Piscaglia 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 21874631Harrois A, Duranteau J. Contrast-enhanced ultrasound: a new vision of microcirculation in the intensive care unit. Crit Care. 2013 Aug 23;17(4):449. doi: 10.1186/cc12860.
PubMed 24103639Seidel 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 19372658Geeraerts T, Merceron S, Benhamou D, Vigue B, Duranteau J. Non-invasive assessment of intracranial pressure using ocular sonography in neurocritical care patients. Intensive Care Med. 2008 Nov;34(11):2062-7. doi: 10.1007/s00134-008-1149-x. Epub 2008 May 29.
PubMed 18509619
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cerebral Microcirculation Using Non-invasive Contrast-enhanced Ultrasound and Microbubbles Sonovue Administration After Clinical Cardiorespiratory Arrest
- ClinicalTrials.gov ID
- NCT04294316
- Acronym / sponsor ID
- B.U.N 143201941163
- Conditions
- Cardiorespiratory Arrest, Microcirculation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 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.
Brain microcirculation alterations may be involved in comatose patients and non-survivors after cardiorespiratory arrest. For a three day-period, we investigate brain microcirculation using contrast-enhanced ultrasound with contrast Sonovue injection in patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest.
Detailed description
Brain ultrasound, extracranial echo-color duplex and ocular ultrasound (IE 33, Philips Medical System, the Netherlands) are performed in the first 24 hours, at 48 hours, and at 72-96 hours after successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest.
Ultrasound examinations are performed in four 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 4) to qualitatively evaluate the intracranial pressure.
Before performing brain ultrasound, echocardiography (IE 33, Philips medical System, the Netherlands) is performed to evaluate the 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 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).
Brain ultrasound is performed via temporal windows to measure the mean flow velocities (cm/sec) of the middle cerebral arteries.
Second, the presence or absence of cerebral autoregulation is tested with the Transient hyperemic response by an ipsilateral common carotid compression one side and another during 5 seconds. Absence of cerebral autoregulation is considered if the flow velocity of the middle cerebral artery do not increase more than 10% after the compression.
Third, the brain regional microcirculation is evaluated by the microbubbles contrast injection of Sonovue. The brain parenchyma is insonated via the temporal bone windows at the depth of 10cm with the ultrasound S5 multifrequency transducer 2-5 Megahertz (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 images are stored digitally on the hard disk as DICOM (Digital Image Communications in Medicine) images. Offline imaging analysis using a specific quantification software named QLAB10 (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, time to peak intensity in seconds, mean transit time in seconds (MTT), and area under the curve in percentage (AUC).
To qualitatively evaluate the intracranial pressure, ocular ultrasound is performed to measure the change of the optic nerve sheath diameter(mm). Elevation of intracranial pressure is considered if this diameter is above 0.55 mm
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ICU patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest who are eligible for enhanced-contrast brain ultrasound with sulphur hexafluoride microbubbles contrast Sonovue examination
| Arm | Type | Receives |
|---|---|---|
| Sonovue group | Other | Diagnostic Test: SonovueICU patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest who are eligible for enhanced-contrast brain ultrasound, extracranial echo-color duplex, and ocular ultrasound. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICU patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest
Key exclusion criteria (15 listed)
- Younger than 18 years old
- Pregnancy
- Acute or history of neurological disorder: stroke, bleeding, trauma, post-neurosurgery, tumor, meningitis.
- Severe dementia, psychiatric or neuromuscular disability
- Untreated Acute coronary syndrome
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 |
|---|---|---|
| SonovueTwice dose of 2.4ml of Sulphur hexafluoride microbubbles contrast Sonovue administration to evaluate brain microcirculation | Diagnostic test | Sonovue group |
Primary outcome
Mean change of the Mean transit time from baseline (seconds)
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Qualitative evaluation of brain microcirculation using the variables of the time-intensity curve after Sonovue administration: a prolonged of Mean transit time is expected in comatose patients or non-survivors.
Mean change of the Peak intensity from baseline (dB).
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Qualitative evaluation of brain microcirculation using the variables of the time-intensity curve after Sonovue administration: a reduction of Peak intensity is expected in comatose patients or non-survivors.
Mean change of the time to Peak intensity from baseline (seconds).
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Qualitative evaluation of brain microcirculation using the variables of the time-intensity curve after Sonovue administration: a reduction of the time to peak intensity is expected in comatose patients or non-survivors.
Mean change of the Area under the curve from baseline (percentage).
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Qualitative evaluation of brain microcirculation using the variables of the time-intensity curve after Sonovue administration: a reduction of the area under the curve is expected in comatose patients or non-survivors.
Testing cerebral autoregulation: Transient Hyperemic test- Absence or presence from baseline
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Absence of cerebral autoregulation is considered if there is no change in flow velocities of the middle cerebral arteries after short compression of the common carotid arteries occur comparing with the value prior to compression.
Mean change of the optic nerve sheath diameter from baseline (mm)
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Qualitative estimation of intracranial pressure using ocular ultrasound to measure the optic nerve sheath diameter. Elevation of intracranial pressure with increase of this diameter above 0.55 mm is expected in comatose patients or non-survivors.
3 secondary outcomes
Mean change of the mean velocities of the middle cerebral arteries from baseline (cm/second)
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Mean change of global cerebral blood flow from baseline (L/minute)
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours
Mean change of cardiac output from baseline (L/minute)
Time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 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 19 May 2020.
- Background: PubMed 31025061Robba C, Goffi A, Geeraerts T, Cardim D, Via G, Czosnyka M, Park S, Sarwal A, Padayachy L, Rasulo F, Citerio G. Brain ultrasonography: methodology, basic and advanced principles and clinical applications. A narrative review. Intensive Care Med. 2019 Jul;45(7):913-927. doi: 10.1007/s00134-019-05610-4. Epub 2019 Apr 25.
- 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 24103639Harrois A, Duranteau J. Contrast-enhanced ultrasound: a new vision of microcirculation in the intensive care unit. Crit Care. 2013 Aug 23;17(4):449. doi: 10.1186/cc12860.
- 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 18509619Geeraerts T, Merceron S, Benhamou D, Vigue B, Duranteau J. Non-invasive assessment of intracranial pressure using ocular sonography in neurocritical care patients. Intensive Care Med. 2008 Nov;34(11):2062-7. doi: 10.1007/s00134-008-1149-x. Epub 2008 May 29.
- 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 Sonovue in people with Cardiorespiratory Arrest 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 1 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 19 May 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 (3224763037, namduc.nguyen@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change of the Mean transit time from baseline (seconds) (time frame: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours). The study lists 6 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 NCT04294316, which also lists 5 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 19 May 2020.