## Protocol Section
### Identification Module
**NCT ID:** NCT06430697

**Acronym:** PAREA

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

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

#### Organization Study ID Info
**ID:** 22-AOI-13
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nice
### Status Module
#### Completion Date
**Date:** 2027-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Nice

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Intensive Care Unit Syndrome

**Keywords:**

- Intensive Care Unit

- PARACETAMOL

- blood pressure

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: paracetamol administration

**Label:** Treatment with paracetamol

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment with paracetamol

**Description:** 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

**Name:** paracetamol administration

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Measure frequency of low blood pressure following paracetamol administration

**Time Frame:** One hour after administration of paracetamol

#### Secondary Outcomes

**Description:** 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.

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

**Time Frame:** One hour after administration of paracetamol

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

**Measure:** identify predictors linked to paracetamol administration route

**Time Frame:** One hour after administration of paracetamol

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

**Measure:** identify predictors linked to paracetamol dosage

**Time Frame:** One hour after administration of paracetamol

**Description:** 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

**Measure:** Measure of blood pressure following paracetamol administration according to SOFA score

**Time Frame:** One hour after administration of paracetamol

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** crc@chu-nice.fr

**Name:** Kamila BURDZENIDZE, Study nurse

**Phone:** 04 92 03 92 20

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nice

**Contacts:**

***Contact 1:***

- **Email:** crc@chu-nice.fr

- **Name:** Kamila BURDZENIDZE, Study nurse

- **Phone:** 04 92 03 92 20

- **Role:** CONTACT

***Contact 2:***

- **Name:** Kamila BURDZENIDZE

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** CHU de NICE ARCHET

**Zip:** 06000

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000058633

- Term: Antipyretics

### Intervention Browse Module - Browse Branches

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M2340

- Name: Acetaminophen

- Relevance: HIGH

- As Found: Vaginal

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M29176

- Name: Antipyretics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000082

- Term: Acetaminophen

### Misc Info Module

- Version Holder: 2024-05-31
