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Cerebral Circulation in Critically Ill Children (CIRCU-REAPED)

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ClinicalTrials.gov Identifier: NCT03731104
Recruitment Status : Not yet recruiting
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The principal purpose of this study is to describe the changes in cerebral circulation (assessed by transcranial ultrasound) and oxygenation (assessed by Near InfraRed spectroscopy, NIRS) during resuscitation for hemodynamic failure (arterial hypotension or shock) in critically ill children treated with vasoactive or inotropic drugs.

The secondary objectives are :

i) to evaluate the association between an alteration of cerebral circulation and/or oxygenation and an alteration in macro-circulatory parameters (Mean Arterial Blood Pressure and cardiac output) or a bad outcome, ii) to study if cerebral autoregulation is impaired


Condition or disease Intervention/treatment
Arterial Hypotension Shock Cerebral Lesion Device: Near InfraRed Spectroscopy assessment Device: Transcranial Doppler Ultrasound assessment Device: Cardiac output assessment

Detailed Description:

Pediatric shock is a frequent and serious cause of hospitalization in pediatric intensive care unit that can lead to multi-organ failure and death.

Its early recognition improves patients' outcome, as well as the establishment of targeted guidelines pursuing normalization of macro-circulatory parameters (ie blood pressure and lactate).

However, regional hypoperfusion leading to organ failure can be present before the alteration of these parameters, and persist after their restoration.

Brain lesions are common in critically ill children with cerebral hypoperfusion, since they may have impaired autoregulation and permeable blood-brain barrier. Vasoactive and inotropic drugs used for hemodynamic resuscitation should restore systemic and regional circulation, but may be inadequate on brain perfusion because of i) their variable and unpredictable cardiovascular effects , and ii) a strong interindividual variability between patients. As such, the impact of this medication on cerebral circulation and oxygenation is unknown.

Monitoring cerebral circulation and oxygenation during a hemodynamic resuscitation using catecholamines is a first step to identify risk factors of an altered brain perfusion, and to improve treatment of shock.


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Cerebral Circulation and Oxygenation During Hemodynamic Resuscitation in Critically Ill Children Without Head Trauma
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Intervention Details:
  • Device: Near InfraRed Spectroscopy assessment

    Regional Cerebral Oxygen saturation (rScO2 ) values will be collected for all patients during the procedure using a 2-wavelength (730-810 nm) cerebral oxymeter (monitor INVOS 5100C®, Medtronics). Two transducers will be placed on both fronto-parietal sides of the patient's head.

    To assess the balance between oxygen delivery and consumption, the Fractional cerebral Tissue Oxygen Extraction (FTOE) will be calculated as this ratio: FTOE=[SpO2-rScO2]/SpO2.

    Data will be collected for a period of 3 hours starting from the beginning of catecholamine treatment.

    Other Name: NIRS assessment
  • Device: Transcranial Doppler Ultrasound assessment

    Transcranial Doppler ultrasound will be performed for all patients during the procedure using a VIVID S-5 (General Electric®) echograph. All examinations will be performed by a single trained operator. A 3 MHz probe will be placed on left and right temporal window to detect signal from the middle cerebral artery. 2 measures will be performed for each side to have the mean of the two measures; In case of difference in measures of more than 20%, a third measure will be performed.

    Measures will be performed for a period of 3 hours starting from the beginning of catecholamine treatment.

    Other Name: TCD assessment
  • Device: Cardiac output assessment

    Transthoracic echocardiography will be realized for all patients during the procedure using a transthoracic ultrasound device (VIVID S-5, General Electric®) with a 3 to 6 MHz probe. All examinations will be performed by a single trained operator.

    Two echocardiographic views will be examined to assess cardiac output : the two-chamber long-axis view to measure sub-aortic diameter (d), and the four-chamber view to measure the Left ventricular outflow tract velocity time integral (LVOT VTI). Cardiac output (Qc) will then be calculated taking account these parameters and heart rate with this formula : Qc = [π x d2 x VTI x HR] / 4 2 measures will be performed to have the mean of the two measures; In case of difference in measures of more than 20%, a third measure will be performed.

    Measures will be performed for a period of 3 hours starting from the beginning of catecholamine treatment.



Primary Outcome Measures :
  1. Near InfraRed Spectroscopy (NIRS) [ Time Frame: 3 hours ]
    rScO2 and FTOE variations (left and right). A cerebral desaturation will be defined by a rScO2 delta >20% from the baseline value (before premedication).

  2. Variations of velocities of middle cerebral artery (left and right), in cm/s [ Time Frame: 3 hours ]
    Transcranial Doppler ultrasound

  3. Variations of pulsatility index of middle cerebral artery (left and right) [ Time Frame: 3 hours ]
    Transcranial Doppler ultrasound

  4. Variations of resistance index of middle cerebral artery (left and right) [ Time Frame: 3 hours ]
    Transcranial Doppler ultrasound


Secondary Outcome Measures :
  1. Mean arterial pressure [ Time Frame: 3 hours ]
    Correlation between microcirculatory parameters (transcranial Doppler ultrasound and NIRS) and mean arterial pressure

  2. Cardiac output calculated with Left ventricular outflow tract velocity time integral (LVOT VTI) measured by cardiac ultrasound [ Time Frame: 3 hours ]
    Correlation between microcirculatory parameters (transcranial Doppler ultrasound and NIRS) and cardiac output (Qc), which will be calculated taking account these parameters and heart rate with this formula : Qc = [π x d2 x VTI x HR] / 4

  3. PEdiatric logistic organ dysfunction score (PELOD-2) [ Time Frame: 3 hours ]

    Correlation between cerebral perfusion (transcranial Doppler ultrasound and NIRS) and Organ Dysfunction assessed by PELOD-2 score.

    PELOD-2 score includes 10 variables corresponding to 5 organ dysfunctions. Values extend from 0 (best outcome) to 33 (worst outcome).


  4. Death in pediatric intensive care unit [ Time Frame: 3 hours ]
    Correlation between cerebral perfusion (transcranial doppler ultrasound and NIRS) and outcome (PELOD-2, death in PICU = pediatric intensive care unit)

  5. Cerebral autoregulation evaluation [ Time Frame: 3 hours ]
    Cerebral autoregulation will be estimated thanks to a Pearson coefficient correlation between mean arterial pressure (MAP) and rScO2. A ratio MAP/rScO2 > 0,5 defines an impaired cerebral autoregulation



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients hospitalized in 2 french Pediatric Intensive Care Units
Criteria

Inclusion Criteria:

Neonates and children from 0 to 18 years old hospitalized in pediatric intensive care unit (PICU) with hemodynamic failure requiring vasoactive or inotropic treatment. This includes :

  • shock (tachycardia, troubles of peripheral perfusion with capillary refill time >3 sec, oliguria, with or without alteration of consciousness or arterial hypotension)
  • isolated arterial hypotension if it needs medical treatment to readjust balance between oxygen demand and oxygen consumption

Exclusion Criteria:

  • primitive cerebral lesion: head trauma, recent history of neurosurgery, sickle cell disease, stroke, brain death, or clinical signs of intracranial hypertension
  • preterm neonates of less than 37 weeks gestational age
  • respiratory and/or circulatory assistance with ECMO
  • patients already receiving more than one catecholamine
  • patients too instable, defined by a respiratory instability (pulse oxymetry of less than 80% during more than 5 minutes) and/or hemodynamic instability (variability of blood pressure and heart rate of more than 50%) and/or cardiorespiratory arrest.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731104


Contacts
Contact: Meryl Vedrenne-Cloquet, MD +33 171396843 meryl.vedrenne@aphp.fr
Contact: Nelly Briand +33 1 44 38 18 62 nelly.briand@aphp.fr

Locations
France
Pediatric Intensive Care Unit, Necker University Hospital Not yet recruiting
Paris, France, 75015
Contact: Meryl Vedrenne-Cloquet, MD    +33 1 71 39 68 43    meryl.vedrenne@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Meryl Vedrenne-Cloquet, MD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03731104     History of Changes
Other Study ID Numbers: 2018-A01392-53
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Near InfraRed Spectroscopy
Brain perfusion
Pediatric shock
Catecholamines

Additional relevant MeSH terms:
Critical Illness
Hypotension
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases