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NCT Number: NCT06430697

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

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...)

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Key information

Conditions

Intensive Care Unit Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de NICE ARCHET

Nice, 06000, France

Location status: Recruiting

Location contact

SACHA CARON

PRINCIPAL_INVESTIGATOR

SACHA CARON, Study nurse

CONTACT

[email protected]

04 92 03 92 20

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Measure frequency of low blood pressure following paracetamol administration

    Time frame: 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

Secondary outcomes

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

    Time frame: One hour after administration of paracetamol

    Identify patients' predictors of low blood pressure following paracetamol administration : Patients' will be identified by measuring frequency of patients with low blood pressure following paracetamol administration, according to The IGS II score (Simplified Severity Index II) is a score used to assess the severity of a patient and is one of the scores used in intensive care and SOFA score.

    Components: The IGS II includes several variables, such as age, chronic health conditions, vital signs, and laboratory values. These factors are combined to calculate a numerical score.

    Scoring: The higher the IGS II score, the greater the predicted risk of mortality. The score ranges from 0 to 100, with higher values indicating more severe illness.

  2. identify predictors linked to paracetamol administration route

    Time frame: One hour after administration of paracetamol

    Measure of blood pressure to identify predictors by measuring frequency of patients with low blood pressure following paracetamol administration, according to administration's route

  3. identify predictors linked to paracetamol dosage

    Time frame: One hour after administration of paracetamol

    Measure of blood pressure to identify predictors by measuring frequency of patients with low blood pressure following paracetamol administration, according to dosage

  4. Measure of blood pressure following paracetamol administration according to SOFA score

    Time frame: One hour after administration of paracetamol

    Identify patients' predictors of low blood pressure following paracetamol administration : Patients' will be identified by measuring frequency of patients with low blood pressure following paracetamol administration, according to the SOFA score.

    The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score,is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure.

    Each system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The worst physiological variables are collected serially every 24 hours of a patient's ICU admission12. The total SOFA score ranges from 0 (best) to 24 (worst) points. It's a valuable tool for predicting clinical outcomes in critically ill patients

Study contacts

Contact information is provided by the study sponsor or research team.

Kamila BURDZENIDZE, Study nurse

CONTACT

[email protected]

04 92 03 92 20

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Prospective Study Evaluating the Hemodynamic Impact of PAracetamol Administration in Patients Hospitalized in the REAnimation Intensive Care Unit

Acronym: PAREA

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 28, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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