Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03731104
Other study ID # 2018-A01392-53
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 13, 2018
Est. completion date July 2, 2021

Study information

Verified date June 2023
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date July 2, 2021
Est. primary completion date July 2, 2021
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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 = [p 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.

Locations

Country Name City State
France Hôpital Necker Paris
France Hôpital Robert Debré Paris
France Hôpital Trousseau Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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 202 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Variations of velocities of middle cerebral artery (left and right), in cm/s Transcranial Doppler ultrasound 3 hours
Primary Variations of pulsatility index of middle cerebral artery (left and right) Transcranial Doppler ultrasound 3 hours
Primary Variations of resistance index of middle cerebral artery (left and right) Transcranial Doppler ultrasound 3 hours
Secondary Mean arterial pressure Correlation between microcirculatory parameters (transcranial Doppler ultrasound and NIRS) and mean arterial pressure 3 hours
Secondary 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 = [p x d2 x VTI x HR] / 4 3 hours
Secondary 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).
3 hours
Secondary 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) 3 hours
Secondary 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 3 hours
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05898126 - Renin-guided Hemodynamic Management in Patients With Shock N/A
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT05066256 - LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock N/A
Not yet recruiting NCT06285513 - Cardiovascular Metabolic Remodeling in Shock
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Terminated NCT02755155 - Optimization of Therapeutic Human Serum Albumin Infusion in Selected Critically Ill Patients Phase 4
Not yet recruiting NCT01941472 - Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness N/A
Terminated NCT01696175 - PICU Admission Lactate and Central Venous Oxymetry Study N/A
Completed NCT01680783 - Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure N/A
Recruiting NCT01174966 - Assessment of Transcutaneous Oxygen Tension/Oxygen Challenge Test in Intensive Care Unit (ICU) Patients N/A
Recruiting NCT01157299 - Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO N/A
Completed NCT00743522 - Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication
Completed NCT03296891 - Point of Care Ultrasonography In The Management of Shock: A Pilot Study N/A
Recruiting NCT05922982 - Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery N/A
Withdrawn NCT04705701 - Comparing Post Cardiac Surgery Outcomes in ESRD Patient's With Early Dialysis Versus Standard Care N/A
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Completed NCT05330676 - Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery
Active, not recruiting NCT04079829 - Postoperative Respiratory Abnormalities
Completed NCT04089098 - VOLume and Vasopressor Therapy in Patients With Hemodynamic instAbility
Completed NCT03190408 - Variation in Fluids Administered in Shock