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Arterial HypotensionCIRCU-REAPEDNCT03731104

Cerebral Circulation in Critically Ill Children

An observational study of Arterial Hypotension and Shock, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 0 to 18 years
Conditions the study is for
Arterial Hypotension, Shock, Cerebral Lesion
What is being tested?
Near InfraRed Spectroscopy assessment, Transcranial Doppler Ultrasound assessment and Cardiac output assessment
Type of treatment
Medical device
How many people
27 participants
Where
3 sitesFrance
Study dates
13 Dec 2018to 2 Jul 2021
Phase
Observational
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 0 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Pediatric patients hospitalized in 4 french Pediatric Intensive Care Units

Who may be able to join

  • 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

Who cannot join

  • primitive cerebral lesion: traumatic or neurosurgical (including brain death states)
  • preterm neonates of less than 37 weeks gestational age
  • 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.

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Hôpital Trousseau

    Paris, 75012

  • Hôpital Necker

    Paris, 75015

  • Hôpital Robert Debré

    Paris, 75019

Other trials in France

About this study

Official title: Changes in Cerebral Circulation and Oxygenation During Hemodynamic Resuscitation in Critically Ill Children Without Head Trauma

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 :

  1. 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
Read the 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.

Being tested
Near InfraRed Spectroscopy assessment, Transcranial Doppler Ultrasound assessment, Cardiac output assessment
Keywords
Near InfraRed Spectroscopy, Brain perfusion, Pediatric shock, Catecholamines
Medical subject headings
Hypotension, Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Near InfraRed Spectroscopy assessmentDevice

    Also called NIRS 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.

  • Transcranial Doppler Ultrasound assessmentDevice

    Also called TCD 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.

  • Cardiac output assessmentDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Near InfraRed Spectroscopy (NIRS)

    rScO2 and FTOE variations (left and right). A cerebral desaturation will be defined by a rScO2 delta >20% from the baseline value (before premedication).

    Measured: 3 hours

  2. Variations of velocities of middle cerebral artery (left and right), in cm/s

    Transcranial Doppler ultrasound

    Measured: 3 hours

  3. Variations of pulsatility index of middle cerebral artery (left and right)

    Transcranial Doppler ultrasound

    Measured: 3 hours

  4. Variations of resistance index of middle cerebral artery (left and right)

    Transcranial Doppler ultrasound

    Measured: 3 hours

Secondary outcomes (5)

  1. Mean arterial pressure

    Correlation between microcirculatory parameters (transcranial Doppler ultrasound and NIRS) and mean arterial pressure

    Measured: 3 hours

  2. Cardiac output calculated with Left ventricular outflow tract velocity time integral (LVOT VTI) measured by cardiac ultrasound

    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

    Measured: 3 hours

  3. PEdiatric logistic organ dysfunction score (PELOD-2)

    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).

    Measured: 3 hours

  4. Death in pediatric intensive care unit

    Correlation between cerebral perfusion (transcranial doppler ultrasound and NIRS) and outcome (PELOD-2, death in PICU = pediatric intensive care unit)

    Measured: 3 hours

  5. Cerebral autoregulation evaluation

    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

    Measured: 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2018
  2. Study start13 Dec 2018
  3. Primary completion2 Jul 2021
  4. Study completion2 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03731104
Sponsor's protocol ID
2018-A01392-53
Acronym
CIRCU-REAPED
Status last verified
Sep 2025
First submitted
17 Aug 2018
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vedrenne-Cloquet M, Chareyre J, Leger PL, Genuini M, Renolleau S, Oualha M. Low Dosing Norepinephrine Effects on Cerebral Oxygenation and Perfusion During Pediatric Shock. Front Pediatr. 2022 Jul 6;10:898444. doi: 10.3389/fped.2022.898444. eCollection 2022.

    PubMed 35874564

Questions about this trial

What is this clinical trial studying?

An observational study of Arterial Hypotension and Shock, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Near InfraRed Spectroscopy (NIRS) (time frame: 3 hours). The study lists 4 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 NCT03731104, which also lists 1 linked publication.

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 12 Sep 2025.

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