The Effect of Paracetamol on Brain Temperature (NEUROTHERM)

July 25, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Hôpital Fondation Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Six hours after administration of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2018

Primary Completion (Actual)

May 26, 2022

Study Completion (Actual)

May 26, 2022

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 24, 2018

First Posted (Actual)

August 27, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDY_2017_19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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