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The Effect of Paracetamol on Brain Temperature (NEUROTHERM)

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ClinicalTrials.gov Identifier: NCT03648021
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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
Brain Injuries Drug: Paracetamol Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 10, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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 Name: 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




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) [ Time Frame: Six hours after administration of treatment ]
    measurement of intracerebral temperature in degrees



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648021


Contacts
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Contact: Amélie YAVCHITZ, MD PhD 0033148036433 ayavchitz@for.paris

Locations
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France
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Amélie YAVCHITZ, MD PhD         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Marine de Mesmay, MD Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03648021    
Other Study ID Numbers: MDY_2017_19
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics