Shock Clinical Trial
— CIRCU-REAPEDOfficial title:
Changes in Cerebral Circulation and Oxygenation During Hemodynamic Resuscitation in Critically Ill Children Without Head Trauma
Verified date | June 2023 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Necker | Paris | |
France | Hôpital Robert Debré | Paris | |
France | Hôpital Trousseau | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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
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 |
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