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NEUROTHERM: The Effect of Paracetamol on Brain Temperature

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Recruiting
CT.gov ID
NCT03648021
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
53.7
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
NEUROTHERM: The Effect of Paracetamol on Brain Temperature in Acute Brain Injury in a Neuro Critical Care Unit: A Randomized Controlled Trial
Actual Study Start Date :
Apr 10, 2018
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: paracetamol (acetaminophen)

patient will receive1 gramme of paracetamol intravenously

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
Other Names:
  • acetaminophen

    		•
    Placebo Comparator: Placebo

    patient will receive 100 ml of chlorure de sodium 0,9% intravenously

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

    Outcome Measures

    Primary Outcome Measures

    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) [Six hours after administration of treatment]

      measurement of intracerebral temperature in degrees

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Fondation Adolphe de Rothschild Paris France 75019

    Sponsors and Collaborators

    • Fondation Ophtalmologique Adolphe de Rothschild

    Investigators

    • Principal Investigator: Marine de Mesmay, MD, Fondation Ophtalmologique Adolphe de Rothschild

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondation Ophtalmologique Adolphe de Rothschild
    ClinicalTrials.gov Identifier:
    NCT03648021
    Other Study ID Numbers:
    • MDY_2017_19
    First Posted:
    Aug 27, 2018
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Injuries
    Acetaminophen

    Study Results

    No Results Posted as of Jul 27, 2022