AzTrials
AzTrials

Acute Circulatory FailureVPP-ImPRoVENCT03225378

Changes in PPV Induced by PLR Test to Predict Fluid Responsiveness in ICU

An observational study of Acute Circulatory Failure, run by Centre Hospitalier Arras at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Circulatory Failure
What is being tested?
Fluid loading of 500 mL of crystalloid solution and Passive Leg Raising test
Type of treatment
Injection or infusion
How many people
286 participants
Where
12 sitesFrance
Study dates
21 Sep 2017to 20 Sep 2021
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

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

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.

Who may be able to join

  • Mechanically ventilated patients
  • Patients in whom the physician decides to perform a fluid challenge based on the presence of one of the following criteria:
  • 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:
Show all 12Show fewer
  • Age <18 yrs
  • Pregnancy
  • Moribund patients
  • Risk of fluid loading induced pulmonary edema
  • Cardiac arrhythmias
  • Contraindication to perform PLR (intracranial hypertension, pelvic fractures)

Who cannot join

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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • CHU d'Amiens - Réanimation Cardio-Thoracique-Vasculaire

    Amiens

  • CHU d'Amiens - Réanimation chirurgicale

    Amiens

  • Centre Hospitalier d'Arras

    Arras

  • Centre Hospitalier de Béthune

    Béthune

  • CH Boulogne-sur-mer

    Boulogne-sur-Mer

  • CHU de Caen

    Caen

  • Centre Hospitalier de Cambrai

    Cambrai

  • CHU de Dijon

    Dijon

  • Centre Hospitalier de Lens - Anesthésie-Réanimation

    Lens

  • Centre Hospitalier de Lens - Réanimation

    Lens

  • CHRU de Lille - Réanimation Médicale

    Lille

  • CHU de Rouen

    Rouen

Other trials in France

About this study

Official title: 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.

Read more

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.

Being tested
Fluid loading of 500 mL of crystalloid solution, Passive Leg Raising test
Keywords
Fluid responsiveness, Passive leg raising, Pulse pressure variation
Medical subject headings
Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluid loading of 500 mL of crystalloid solutionOther

    Infusion of 500 mL of crystalloid solution in less than 15 minutes

  • Passive Leg Raising testOther

    This intervention is done before the fluid loading in order to predict fluid responsiveness.

Study groups in NCT03225378
Study groupRoleWhat they receive
Acute circulatory failureMechanically 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.
Receives: Other: Fluid loading of 500 mL of crystalloid solution; Other: Passive Leg Raising test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Increase in cardiac output in all mechanically ventilated patients

    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.

    Measured: Cardiac output will be measured immediately after the end of the volume expansion

Secondary outcomes (2)

  1. Increase in cardiac output in mechanically ventilated patients with spontaneous breathing activities

    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.

    Measured: Cardiac output will be measured immediately after the end of the volume expansion

  2. Increase in cardiac output in mechanically ventilated patients with low tidal ventilation and/or low respiratory compliance

    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.

    Measured: Cardiac output will be measured immediately after the end of the volume expansion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start21 Sep 2017
  3. Primary completion20 Sep 2021
  4. Study completion20 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
286 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT03225378
Sponsor's protocol ID
2017_01
Acronym
VPP-ImPRoVE
Status last verified
Oct 2021
First submitted
20 Jul 2017
Last updated
27 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Monnet X, Marik P, Teboul JL. Passive leg raising for predicting fluid responsiveness: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1935-1947. doi: 10.1007/s00134-015-4134-1. Epub 2016 Jan 29.

    PubMed 26825952

  • Cherpanath TG, Hirsch A, Geerts BF, Lagrand WK, Leeflang MM, Schultz MJ, Groeneveld AB. Predicting Fluid Responsiveness by Passive Leg Raising: A Systematic Review and Meta-Analysis of 23 Clinical Trials. Crit Care Med. 2016 May;44(5):981-91. doi: 10.1097/CCM.0000000000001556.

    PubMed 26741579

  • Mallat J, Meddour M, Durville E, Lemyze M, Pepy F, Temime J, Vangrunderbeeck N, Tronchon L, Thevenin D, Tavernier B. Decrease in pulse pressure and stroke volume variations after mini-fluid challenge accurately predicts fluid responsivenessdagger. Br J Anaesth. 2015 Sep;115(3):449-56. doi: 10.1093/bja/aev222. Epub 2015 Jul 6.

    PubMed 26152341

  • Mallat J, Abou-Arab O, Lemyze M, Saleh D, Guinot PG, Fischer MO. Changes in central venous-to-arterial PCO2 difference and central venous oxygen saturation as markers to define fluid responsiveness in critically ill patients: a pot-hoc analysis of a multi-center prospective study. Crit Care. 2024 Nov 8;28(1):360. doi: 10.1186/s13054-024-05156-y.

    PubMed 39516883

  • Mallat J, Lemyze M, Fischer MO. Passive leg raising test induced changes in plethysmographic variability index to assess fluid responsiveness in critically ill mechanically ventilated patients with acute circulatory failure. J Crit Care. 2024 Feb;79:154449. doi: 10.1016/j.jcrc.2023.154449. Epub 2023 Oct 17.

    PubMed 37857068

  • Mallat J, Fischer MO, Granier M, Vinsonneau C, Jonard M, Mahjoub Y, Baghdadi FA, Preau S, Poher F, Rebet O, Bouhemad B, Lemyze M, Marzouk M, Besnier E, Hamed F, Rahman N, Abou-Arab O, Guinot PG. Passive leg raising-induced changes in pulse pressure variation to assess fluid responsiveness in mechanically ventilated patients: a multicentre prospective observational study. Br J Anaesth. 2022 Sep;129(3):308-316. doi: 10.1016/j.bja.2022.04.031. Epub 2022 Jul 14.

    PubMed 35842352

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Circulatory Failure, run by Centre Hospitalier Arras at 12 sites 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 12 inclusion and 2 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: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increase in cardiac output in all mechanically ventilated patients (time frame: Cardiac output will be measured immediately after the end of the volume expansion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03225378, which also lists 6 linked publications.

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 27 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in