Changes in PPV Induced by PLR Test to Predict Fluid Responsiveness in ICU (VPP-ImPRoVE)

October 26, 2021 updated by: Centre Hospitalier Arras

Changes in Pulse Pressure Variations Induced by Passive Leg Raising Test to Predict Fluid Responsiveness in ICU

The passive leg raising (PLR) test is a reversible preload challenge of around 300 mL of blood that can be repeated as frequently as required without infusing a drop of fluid. Two recent meta-analyses of many studies have confirmed the reliability of the PLR test to predict fluid responsiveness in patients with acute circulatory failure. Nevertheless, the effects of the PLR must be assessed by the direct measurement of cardiac output since changes in arterial pressure do not allow the assessment of the PLR hemodynamic effects with reliability. Moreover, cardiac output must be measured continuously and in real time.

In clinical practice, cardiac output measurement can be difficult for different reasons such as the unavailability of the echocardiography machine, or the absence of any continuous cardiac output monitoring technique at the time of acute circulatory failure occurrence.

Recently, it was shown that the decrease in pulse pressure variation (PPV) induced by the mini-fluid challenge (100 mL of colloid solution infused in 1 min) was able to predict fluid responsiveness with reliability in patients ventilated with low tidal volume (<8 mL/kg of ideal body weight).

Therefore, the investigators hypothesize that the changes in PPV induced by PLR test could be able to predict fluid responsiveness with reliability in mechanically ventilated patients with acute circulatory failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

286

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
      • Amiens, France
        • CHU d'Amiens - Réanimation Cardio-Thoracique-Vasculaire
      • Amiens, France
        • CHU d'Amiens - Réanimation chirurgicale
      • Arras, France
        • Centre Hospitalier D'arras
      • Bethune, France
        • Centre Hospitalier de Béthune
      • Boulogne-sur-Mer, France
        • CH Boulogne-sur-Mer
      • Caen, France
        • CHU de Caen
      • Cambrai, France
        • Centre Hospitalier de Cambrai
      • Dijon, France
        • CHU de Dijon
      • Lens, France
        • Centre Hospitalier de Lens - Anesthésie-Réanimation
      • Lens, France
        • Centre Hospitalier de Lens - Réanimation
      • Lille, France
        • CHRU de Lille - Réanimation Médicale
      • Rouen, France
        • CHU de Rouen

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mechanically ventilated patients displaying acute circulatory failure signs in whom the physician decides to perform a fluid challenge and a PLR test to predict fluid responsiveness.

Description

Inclusion Criteria:

  • Mechanically ventilated patients

  • Patients in whom the physician decides to perform a fluid challenge based on the presence of one of the following criteria:

    (1) systolic arterial pressure <90 mmHg, mean arterial pressure <65 mmHg, or the need for vasopressor infusion; (2) skin mottling; (3) urine output <0.5 mL/Kg/h for more than or equal to 2 hours; (4) lactate concentrations > 2 mmol/L

  • Patients in whom the physician decides to perform a PLR test to predict fluid responsiveness
  • Arterial catheter should be in place for invasive monitoring of arterial pressure and PPV

Non inclusion Criteria:

  • Age <18 yrs
  • Pregnancy
  • Moribund patients
  • Risk of fluid loading induced pulmonary edema
  • Cardiac arrhythmias
  • Contraindication to perform PLR (intracranial hypertension, pelvic fractures)

Exclusion Criteria :

  • Changes in vasopressor and sedation agents dosages during the protocol
  • Changes in ventilatory parameters during the protocol

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
Intervention / Treatment
Acute circulatory failure
Mechanically ventilated patients displaying acute circulatory failure in whom the physician decides to perform a fluid challenge (fluid loading of 500 mL of crystalloid solution) and a passive leg raising test to predict fluid responsiveness.
Other: Fluid loading of 500 mL of crystalloid solution
Infusion of 500 mL of crystalloid solution in less than 15 minutes
Other: Passive Leg Raising test
This intervention is done before the fluid loading in order to predict fluid responsiveness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in cardiac output in all mechanically ventilated patients
Time Frame: Cardiac output will be measured immediately after the end of the volume expansion
The primary endpoint is the increase in cardiac output of more than or equal to 15% after 500 mL of volume expansion. All included patients are concerned by the primary outcome.
Cardiac output will be measured immediately after the end of the volume expansion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in cardiac output in mechanically ventilated patients with spontaneous breathing activities
Time Frame: Cardiac output will be measured immediately after the end of the volume expansion
The secondary endpoint is the increase in cardiac output of more than or equal to 15% after 500 mL of volume expansion. Only patients with spontaneous breathing activities are concerned by this secondary outcome.
Cardiac output will be measured immediately after the end of the volume expansion
Increase in cardiac output in mechanically ventilated patients with low tidal ventilation and/or low respiratory compliance
Time Frame: Cardiac output will be measured immediately after the end of the volume expansion
The secondary endpoint is the increase in cardiac output of more than or equal to 15% after 500 mL of volume expansion. Only patients with low tidal ventilation (<8mL/kg of ideal body weight) and/or low respiratory compliance (<30mL/cmH2O) are concerned by this secondary outcome.
Cardiac output will be measured immediately after the end of the volume expansion

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Arras

Investigators

  • Principal Investigator: Jihad MALLAT, MD, Centre Hospitalier Arras

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 21, 2017

Primary Completion (ACTUAL)

September 20, 2021

Study Completion (ACTUAL)

September 20, 2021

Study Registration Dates

First Submitted

July 20, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (ACTUAL)

July 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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