Arterial Pressure Derived Dynamic Parameters to Detect Preload Responsiveness in Spontaneously Breathing Patients

February 17, 2026 updated by: CHU de Reims

The Performance of Changes of Pulse Pressure and of Pulse Pressure Variation to Detect Preload Responsiveness in Spontaneously Breathing Patients

The management of septic shock patients includes the infusion of fluids, however fluids may be deleterious if the patient does not respond by increasing cardiac output. By consequence, it is now recommended to predict the fluid response (fluid or preload responsiveness) before infusing them. In this protocol, the investigators will include critically ill patients spontaneously breathing, for whom the physician in charge has decided to test preload responsiveness. The investigators will collect from the continuous monitoring of arterial pressure of the patient the pulse pressure(PP) which is the difference between systolic arterial pressure and diastolic arterial pressure and the pulse pressure variation (PPV) automatically displayed by the monitor in addition to other clinical (hemodynamic, respiratory) parameters. After one minute of passive leg raising manoeuvre (PLR) the investigators collect the same parameters and the investigators will compare the changes of these parameters in patients who are preload responsive to patients who are not. Preload responsiveness will de defined by echocardiographic parameters before and during PLR. More exactly, a surrogate of cardiac output measured by echocardiography wich is VTI of the sub-aorti flow; an increase of more than 12% defines apreload responsive patient.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

*Objectives:

Primary : to assess the diagnostic performance of the decrease in pulse pressure variation (PPV) during a passive leg raising test (PLR) to predict preload responsiveness in spontaneously breathing patients hospitalized in intensive care.

Secondary:

  • Evaluate the diagnostic performance of the increase in pulse pressure (PP) during a PLR test to predict preload responsiveness in this same population.

  • Compare before/after PLR measurements other hemodynamic data (blood pressure, cardiac output, heart rate).

    • Experimental scheme: it is a diagnostic and monocentric study.
    • Population / patients:

Inclusion criteria:

  • Patient over 18 years old.
  • Hospitalized in intensive care.

  • For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:

    • Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.
    • And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia).
  • In spontaneous ventilation and without ventilatory assistance.
  • Previously equipped with an arterial catheter.
  • Affiliated to a social security scheme.

Non-inclusion criteria:

  • Patient with arrythmia (PPV is not applicable).
  • Patient with intra-abdominal hypertension (PLR test is not valid).
  • Patient with a contraindication/impossibility to the PLR maneuver (lower limb amputation, respiratory intolerance).
  • Patient with poor echogenicity noted previously.

  • Patient protected by law.

    • Investigation Plan:

Patients meeting the inclusion criteria and not presenting any non-inclusion criteria may be included. The patient will be informed, or his/her relatives if he/she is unable to express their will, of the objectives and the progress of the study. If the patient, or his/her relatives, does not object to participate to the study, the course of the study will be as follows:

  1. The following measurements will be performed before and after the PLR test in spontaneously breathing patients (SB) to evaluate the preload dependency:

    • Hemodynamic data: systolic (SAP), diastolic (DAP), mean (MAP), pulse pressure (PP), heart rate (HR), value of the Pulse Pressure Variation (PPV), cardiac index (CI) if cardiac output monitoring is already present.
    • Echographic data including: time-velocity integral of sub-aortic flow VTI Sub AO); aortic outflow chamber diameter (Diam outflow tract); data from the transmitral pulsed Doppler as well as the data from the tissue Doppler at the mitral annulus (E wave velocity; A wave; E' wave); left ventricular end-diastolic surface.
  2. Collection of demographic parameters (age, sex, comorbidities), acute pathology and severity scores (SAPSII, APACHE II, SOFA) in the patient file.
  3. Collection of oxygenation parameters: mode (conventional oxygen therapy or High Flow), Fio2 or liter O2/min, Flow if applicable.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

  • Patient over 18 years old.
  • Hospitalized in intensive care.

  • For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:

    • Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.
    • And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia) :
  • In spontaneous ventilation and without ventilatory assistance.
  • Previously equipped with an arterial catheter.
  • Affiliated to a social security scheme.

Description

Inclusion Criteria:

  • Patient over 18 years old.
  • Hospitalized in intensive care.

  • For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:

    • Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.
    • And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia) :
  • In spontaneous ventilation and without ventilatory assistance.
  • Previously equipped with an arterial catheter.
  • Affiliated to a social security scheme.

Exclusion Criteria:

  • Patient with arrythmia (PPV is not applicable).
  • Patient with intra-abdominal hypertension (PLR test is not valid).
  • Patient with a contraindication/impossibility to the PLR maneuver (lower limb amputation, respiratory intolerance).
  • Patient with poor echogenicity noted previously.
  • Patient protected by law.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Positive PLR test (PLR +)
  • Patient over 18 years old.
  • Hospitalized in intensive care.

  • For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:

    • Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.
    • And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia) :
  • In spontaneous ventilation and without ventilatory assistance.
  • Previously equipped with an arterial catheter.
Other: Detection of preload responders by a PLR test
Detection of preload dependency by using PLR test and echocardiography
Negative PLR test (PLR-)
  • Patient over 18 years old.
  • Hospitalized in intensive care.

  • For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:

    • Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.
    • And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia) :
  • In spontaneous ventilation and without ventilatory assistance.
  • Previously equipped with an arterial catheter.
Other: Detection of preload responders by a PLR test
Detection of preload dependency by using PLR test and echocardiography

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic performance of the decrease in Pulse Pressure Variation (PPV) during a Passive Leg Raising test (PLR) to predict preload responsiveness
Time Frame: Day 1
To assess the diagnostic performance of the decrease in pulse pressure variation (PPV) during a passive leg raising test (PLR) to predict preload responsiveness in spontaneously breathing patients hospitalized in intensive care.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate the diagnostic performance of the increase in pulse pressure (PP) during a PLR test to predict preload responsiveness
Time Frame: Day 1
Evaluate the diagnostic performance of the increase in pulse pressure (PP) during a PLR test to predict preload responsiveness in spontaneously breathing patients hospitalized in intensive care.
Day 1
Compare PLR measurements other hemodynamic data
Time Frame: Day 1
Compare before/after PLR measurements other hemodynamic data in spontaneously breathing patients hospitalized in intensive care.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PO24013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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