Back to resultsThe Effect of Paracetamol on Brain Temperature (NEUROTHERM)
Primary Purpose
Brain Injuries
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Paracetamol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injuries
Eligibility Criteria
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
Sites / Locations
- Hôpital Fondation Adolphe de Rothschild
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
paracetamol (acetaminophen)
Placebo
Arm Description
patient will receive1 gramme of paracetamol intravenously
patient will receive 100 ml of chlorure de sodium 0,9% intravenously
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03648021
First Posted
August 3, 2018
Last Updated
July 25, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT03648021
Brief Title
The Effect of Paracetamol on Brain Temperature
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
May 26, 2022 (Actual)
Study Completion Date
May 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
paracetamol (acetaminophen)
Arm Type
Active Comparator
Arm Description
patient will receive1 gramme of paracetamol intravenously
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patient will receive 100 ml of chlorure de sodium 0,9% intravenously
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
acetaminophen
Intervention Description
>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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100mL of chlorure de sodium 0.9% administred intravenously. 1 dose
Primary Outcome Measure Information:
Title
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)
Description
measurement of intracerebral temperature in degrees
Time Frame
Six hours after administration of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marine de Mesmay, MD
Organizational Affiliation
Fondation Ophtalmologique Adolphe de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Fondation Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
The Effect of Paracetamol on Brain Temperature
We'll reach out to this number within 24 hrs