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Completed

NCT Number: NCT03648021

The Effect of Paracetamol on Brain Temperature

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.

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

>50kg: Paracetamol 1 gramme in a solution of 10mg/mL administred intravenously. 1 dose

>50kg: Paracetamol 15mg/kg/dose in a solution 10mg/mL administred intravenously. 1 dose

Other names: acetaminophen

Placebo

Drug

100mL of chlorure de sodium 0.9% administred intravenously. 1 dose

Primary outcomes

  1. 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)

    Time frame: Six hours after administration of treatment

    measurement of intracerebral temperature in degrees

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

NEUROTHERM: The Effect of Paracetamol on Brain Temperature in Acute Brain Injury in a Neuro Critical Care Unit: A Randomized Controlled Trial

Acronym: NEUROTHERM

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2018
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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