Cerebral Circulation in Critically Ill Children

NCT03731104 | Completed

• 1 other identifier: 2018-A01392-53
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 3

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

Conditions

Arterial Hypotension; Shock; Cerebral Lesion

Keywords

Near InfraRed Spectroscopy; Brain perfusion; Pediatric shock; Catecholamines

Outcome Measures

Primary Outcomes (4)

• 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).

  3 hours

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

  Transcranial Doppler ultrasound

  3 hours

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

  Transcranial Doppler ultrasound

  3 hours

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

  Transcranial Doppler ultrasound

  3 hours

Secondary Outcomes (5)

• Mean arterial pressure

  3 hours

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

  3 hours

• PEdiatric logistic organ dysfunction score (PELOD-2)

  3 hours

• Death in pediatric intensive care unit

  3 hours

• Cerebral autoregulation evaluation

  3 hours

Interventions

Near InfraRed Spectroscopy assessment DEVICE

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.

Also known as: NIRS assessment

Transcranial Doppler Ultrasound assessment DEVICE

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.

Also known as: TCD assessment

Cardiac output assessment DEVICE

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.

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients hospitalized in 4 french Pediatric Intensive Care Units

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (3)

Hôpital Trousseau

Paris, 75012, France

Location

Hôpital Necker

Paris, 75015, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

Related Publications (1)

• 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.

  PMID: 35874564 BACKGROUND

MeSH Terms

Conditions

Hypotension; Shock

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meryl VEDRENNE-CLOQUET, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: November 6, 2018
• Study Start: December 13, 2018
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)