Enhanced-contrast Brain Ultrasound in Cardiorespiratory Arrest

NCT04294316 | Unknown DMC

• 1 other identifier: B.U.N 143201941163
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 in-hospital cardiorespiratory arrest.

Conditions

Cardiorespiratory Arrest; Microcirculation

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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)

  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)

  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)

  Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 hours and at 72 or 96 hours

Study Arms (1)

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.

Diagnostic Test: Sonovue

Interventions

Sonovue DIAGNOSTIC_TEST

Twice dose of 2.4ml of Sulphur hexafluoride microbubbles contrast Sonovue administration to evaluate brain microcirculation

Sonovue group

Eligibility Criteria

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

You may qualify if:

• ICU patients with successful resuscitation after out-hospital or in-hospital cardiorespiratory arrest

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair ziekenhuis Brussel

Brussels, 1200, Belgium

RECRUITING

Related Publications (5)

• 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.

  PMID: 31025061 BACKGROUND

• 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

• Harrois 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.

  PMID: 24103639 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

• Geeraerts 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.

  PMID: 18509619 BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Duc Nam Nguyen, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duc Nam Nguyen, MD, PhD

CONTACT

3224763037; namduc.nguyen@uzbrussel.be

Godelieve Opdenacker, Study nurse

CONTACT

00322477; 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: 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

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 4, 2020
• Study Start: November 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)