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NCT Number: NCT03225378

Changes in PPV Induced by PLR 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.

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Key information

Conditions

Acute Circulatory Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Amiens - Réanimation Cardio-Thoracique-Vasculaire, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid loading of 500 mL of crystalloid solution

Other

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

Passive Leg Raising test

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Arras

Other

Registry information

Official study title

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

Acronym: VPP-ImPRoVE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2017
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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