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

NCT06430697 | Not Yet Recruiting

• 1 other identifier: 22-AOI-13
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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...)

Conditions

Intensive Care Unit Syndrome

Keywords

Intensive Care Unit; PARACETAMOL; blood pressure

Outcome Measures

Primary Outcomes (1)

• Measure frequency of low blood pressure following paracetamol administration

  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

  One hour after administration of paracetamol

Secondary Outcomes (4)

• Measure of blood pressure following paracetamol administration according to IGS II score

  One hour after administration of paracetamol

• identify predictors linked to paracetamol administration route

  One hour after administration of paracetamol

• identify predictors linked to paracetamol dosage

  One hour after administration of paracetamol

• Measure of blood pressure following paracetamol administration according to SOFA score

  One hour after administration of paracetamol

Study Arms (1)

Treatment with paracetamol

EXPERIMENTAL

Drug: paracetamol administration

Interventions

paracetamol administration 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

Treatment with paracetamol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE ARCHET

Nice, 06000, France

Location

Central Study Contacts

Kamila BURDZENIDZE, Study nurse

CONTACT

04 92 03 92 20; crc@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 28, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

FR (1)