Brain Ultrasound With Contrast Microbubbles Injection in Shock Status

NCT04290767 | Unknown DMC

• 1 other identifier: B.U.N. 143201421588
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 cerebral blood flow, and to evaluate the brain microcirculation, using variables of the time-intensity brain perfusion curve, after sulphur hexafluoride microbubble Sonovue injection.

Conditions

Shock; Microcirculation

Keywords

Shock; Brain microcirculattion; Enhanced-contrast brain ultrasound; Sulphur hexafluoride microbubbles contrast Sonovue

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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

  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

  Comparison to baseline (24 hours after ICU admission) to the second (48 hours) and third timepoints (72 or 96 hours)

Study Arms (1)

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.

Diagnostic Test: Sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy)

Interventions

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.

Sonovue

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

Related Publications (4)

• 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.

  PMID: 21874631 BACKGROUND

• Powers 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.

  PMID: 19372657 BACKGROUND

• Seidel 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.

  PMID: 19372658 BACKGROUND

• Wiesmann 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.

  PMID: 11022074 BACKGROUND

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Duc Nam Nguyen, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duc Nam Nguyen, MD, PhD

CONTACT

3224775178; namduc.nguyen@uzbrussel.be

Godelieve Opdenacker, Study nurse

CONTACT

3224775178; godelieve.opdenacker@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Cohort study in a single center

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: March 2, 2020
• Study Start: March 6, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)