CompletedPhase 4

The Effect of Paracetamol on Brain Temperature

France100 participantsStarted 2018-05-03

Plain-language summary

The main objective of this study is to compare the effect of intravenous paracetamol administration on mean brain temperature (measured between H0 and H6) in patients with cerebral hyperthermia versus placebo. The investigators will measure brain temperature using a thermistor that will be connected to the intracranial pressure transducer.

Who can participate

Age range

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 * 18-year or older patients * Patient hospitalized in neuro-critical care for: * Arachnoid hemorrhage * Intra parenchymatous hematoma * stroke * Acute brain Severe injury * Post-operative complication of an act of neurosurgery or programmed neuroradiology * Sedation and mechanical ventilation planned \> 2 days * Monitoring of intracranial temperature and pressure by intraparenchymal sensor (Sophysa®) * Brain temperature \> 38.5°C for more than 30 minutes Exclusion Criteria * Known hypersensitivity to paracetamol or mannitol (excipient with known effect) * Severe hepatocellular insufficiency (ASAT or ALAT \> 5N, or bilirubin \> 2N) * Pharmacological intervention (administration of corticosteroids, NSAIDs or paracetamol) or physical intervention (external cooling technique) that may influence temperature in the last 6 hours. * Pregnant or breastfeeding women * Previous participation in this study

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

Comparison of mean brain temperature measured between H0 and H6 following administration of treatment between the two groups (the group treated with paracetamol and the placebo group)

Timeframe: Six hours after administration of treatment

Trial details

NCT IDNCT03648021

SponsorFondation Ophtalmologique Adolphe de Rothschild

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2022-05-26

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