Hemodynamic Impact of the Administration of PAracetamol in Patients Hospitalized in the Intensive Resuscitation Medicine Department [PAREA]

NCT ID: NCT06430697

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2027-04-30

Brief Summary

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Paracetamol is commonly used in case of pain or fever. Few previously clinical studies has highlighted an arterial hypotension linked to intravenous administration of paracetamol. Currently, fewer data are available on the link of intravenous administration of paracetamol and effects on arterial tension. The aim of this study is to describe the frequency of occurrence of significative arterial hypotension within one hour following intravenous or per os administration of paracetamol . Other factors who can be associated to occurence of significative arterial hypotension will be also observe (for example age, weight, pain, vasopressor dosage or sedative...)

Detailed Description

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Conditions

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Intensive Care Unit Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment with paracetamol

Group Type EXPERIMENTAL

paracetamol administration

Intervention Type DRUG

Patient hospitalized in Intensive Care Unit with a continuous measurement of blood pressure with a catheter and who have an administration of paracetamol by intravenous or per os

Interventions

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paracetamol administration

Patient hospitalized in Intensive Care Unit with a continuous measurement of blood pressure with a catheter and who have an administration of paracetamol by intravenous or per os

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion:

* 18 years of age or older
* Patient with arterial catheter
* Indication of paracetamol's administration by the patient's attending practitioner.
* No opposition to patient or support person participation in the study if the patient is unable to participate

ExclusionCriteria:

* No Social Security Patient
* Pregnant or nursing patient.
* Patient with a legal protection measure
* Hypersensitivity and/or allergy to paracetamol.
* Contraindication to the use of paracetamol.
* Patient opposition to health data collection.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de NICE ARCHET

Nice, , France

Site Status

Countries

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France

Central Contacts

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Kamila BURDZENIDZE, Study nurse

Role: CONTACT

04 92 03 92 20

Facility Contacts

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Kamila BURDZENIDZE, Study nurse

Role: primary

04 92 03 92 20

Other Identifiers

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22-AOI-13

Identifier Type: -

Identifier Source: org_study_id

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