Hemodynamic Impact of the Administration of PAracetamol in Patients Hospitalized in the Intensive Resuscitation Medicine Department [PAREA]
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: paracetamol administration.
- Who it may be relevant to
- Registry conditions: Intensive Care Unit Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Study Evaluating the Hemodynamic Impact of PAracetamol Administration in Patients Hospitalized in the REAnimation Intensive Care Unit
Overview
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...)
Interventions
- Drug 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
Primary outcome measures
- Measure frequency of low blood pressure following paracetamol administration [Time frame: One hour after administration of paracetamol]
Secondary outcome measures (4)
- Measure of blood pressure following paracetamol administration according to IGS II score [Time frame: One hour after administration of paracetamol]
- identify predictors linked to paracetamol administration route [Time frame: One hour after administration of paracetamol]
- identify predictors linked to paracetamol dosage [Time frame: One hour after administration of paracetamol]
- Measure of blood pressure following paracetamol administration according to SOFA score [Time frame: One hour after administration of paracetamol]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- CHU de NICE ARCHET — Nice
Identifiers
NCT: NCT06430697 · 22-AOI-13