The Effect of Paracetamol on Brain Temperature

Brain Injuries Clinical Trial

— NEUROTHERM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648021
• Other study ID #: MDY_2017_19
• Status: Completed
• Phase: Phase 4
• Start date: May 3, 2018
• Est. completion date: May 26, 2022

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 26, 2022
• Est. primary completion date: May 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Drug:
• Paracetamol
>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
• Placebo
100mL of chlorure de sodium 0.9% administred intravenously. 1 dose

Locations

Country	Name	City	State
France	Hôpital Fondation Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	measurement of intracerebral temperature in degrees	Six hours after administration of treatment