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Recruiting Not applicable

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

NCT06430697 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-02-03
Last updated
2026-05-26

Condition(s) studied

Intensive Care Unit Syndrome

Investigational drug(s) / intervention(s)

paracetamol administration

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

Study summary

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...)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Measure frequency of low blood pressure following paracetamol administration — One hour after administration of paracetamol
    Proportion of patients with clinically significant low blood pressure occurring within one hour of administration of paracetamol IV or per os. Clinically significant low blood pressure is defined as an average blood pressure of less than 60 mmHg and/or a decrease in average blood pressure of more than 15%, and/or need for vascular filling and/or initiation or increase of the dose of noradrenaline

Trial sites (1)

FacilityCityRegionStatus
CHU de NICE ARCHET Nice France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06430697 on ClinicalTrials.gov ↗ ← All trials in France