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

Cerebral Circulation in Critically Ill Children

Sponsors

Lead sponsor: Assistance Publique - Hôpitaux de Paris

Source 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

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.

Overall Status Recruiting
Start Date December 13, 2018
Completion Date January 2022
Primary Completion Date January 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Near InfraRed Spectroscopy (NIRS) 3 hours
Variations of velocities of middle cerebral artery (left and right), in cm/s 3 hours
Variations of pulsatility index of middle cerebral artery (left and right) 3 hours
Variations of resistance index of middle cerebral artery (left and right) 3 hours
Secondary Outcome
Measure Time Frame
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
Enrollment 50
Condition
Intervention

Intervention type: Device

Intervention name: Near InfraRed Spectroscopy assessment

Description: 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

Intervention type: Device

Intervention name: Transcranial Doppler Ultrasound assessment

Description: 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

Intervention type: Device

Intervention name: Cardiac output assessment

Description: 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

Sampling method: Non-Probability Sample

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: 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.

Gender: All

Minimum age: N/A

Maximum age: 18 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Meryl VEDRENNE-CLOQUET, MD Principal Investigator Assistance Publique - Hôpitaux de Paris
Overall Contact

Last name: Meryl VEDRENNE-CLOQUET, MD

Phone: +33 1 71 39 68 43

Email: [email protected]

Location
facility status contact
Hôpital Trousseau | Paris, 75012, France Recruiting Pierre-Louis LEGER, MD [email protected]
Hôpital Necker | Paris, 75015, France Recruiting Meryl VEDRENNE-CLOQUET, MD +33 1 71 39 68 43 [email protected] Estelle VERGNAUD, MD Sub-Investigator
Hôpital Robert Debré | Paris, 75019, France Recruiting Mathieu GENUINI, MD [email protected]
Location Countries

France

Verification Date

April 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym CIRCU-REAPED
Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov