CompletedNot Applicable

Cerebral Circulation in Critically Ill Children

France27 participantsStarted 2018-12-13

Plain-language 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

Who can participate

Age range

0 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Near InfraRed Spectroscopy (NIRS)

Timeframe: 3 hours

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

Timeframe: 3 hours

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

Timeframe: 3 hours

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

Timeframe: 3 hours

Trial details

NCT IDNCT03731104

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-07-02

View on ClinicalTrials.gov More Arterial Hypotension trials

Plain-language summary

Who can participate

Age range

0 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Near InfraRed Spectroscopy (NIRS)

Timeframe: 3 hours

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

Timeframe: 3 hours

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

Timeframe: 3 hours

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

Timeframe: 3 hours