Intensive Care Unit SyndromePAREANCT06430697
Hemodynamic Impact of the Administration of PAracetamol in Patients Hospitalized in the Intensive Resuscitation Medicine Department [PAREA]
A study testing paracetamol administration in people with Intensive Care Unit Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Syndrome
- What is being tested?
- paracetamol administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de NICE ARCHET
Nice, 06000
SACHA CARON, Study nurse, 04 92 03 92 20, crc@chu-nice.fr
SACHA CARON
About this study
Official title: Prospective Study Evaluating the Hemodynamic Impact of PAracetamol Administration in Patients Hospitalized in the REAnimation Intensive Care Unit
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
- Being tested
- paracetamol administration
- Keywords
- Intensive Care Unit, PARACETAMOL, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamol administrationDrug
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 group | Role | What they receive |
|---|---|---|
| Treatment with paracetamol | Experimental | Not described Receives: Drug: paracetamol administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One hour after administration of paracetamol
Secondary outcomes (4)
Measure of blood pressure following paracetamol administration according to IGS II score
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.
Measured: One hour after administration of paracetamol
identify predictors linked to paracetamol administration route
Measure of blood pressure to identify predictors by measuring frequency of patients with low blood pressure following paracetamol administration, according to administration's route
Measured: One hour after administration of paracetamol
identify predictors linked to paracetamol dosage
Measure of blood pressure to identify predictors by measuring frequency of patients with low blood pressure following paracetamol administration, according to dosage
Measured: One hour after administration of paracetamol
Measure of blood pressure following paracetamol administration according to SOFA score
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
Measured: One hour after administration of paracetamol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start3 Feb 2025
- Primary completionAug 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430697
- Sponsor's protocol ID
- 22-AOI-13
- Acronym
- PAREA
- Status last verified
- May 2026
- First submitted
- 16 May 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Hemodynamic Impact of PAracetamol Administration in Patients Hospitalized in the REAnimation Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06430697
- Acronym / sponsor ID
- PAREA / 22-AOI-13
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- Intensive Care Unit, PARACETAMOL, blood pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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...)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with paracetamol | Experimental | Drug: paracetamol administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- No Social Security Patient
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paracetamol administrationPatient 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 | Drug | Treatment with paracetamol |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paracetamol administration in people with Intensive Care Unit Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kamila BURDZENIDZE, Study nurse (04 92 03 92 20, crc@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure frequency of low blood pressure following paracetamol administration (time frame: One hour after administration of paracetamol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.