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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03225378
Acronym
VPP-ImPRoVE
Enrollment
286
Registered
2017-07-21
Start date
2017-09-21
Completion date
2021-09-20
Last updated
2021-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Circulatory Failure

Keywords

Fluid responsiveness, Passive leg raising, Pulse pressure variation

Brief 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 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.

Interventions

OTHERFluid loading of 500 mL of crystalloid solution

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

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

Sponsors

Centre Hospitalier Arras
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Increase in cardiac output in all mechanically ventilated patientsCardiac output will be measured immediately after the end of the volume expansionThe 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

MeasureTime frameDescription
Increase in cardiac output in mechanically ventilated patients with spontaneous breathing activitiesCardiac output will be measured immediately after the end of the volume expansionThe 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.
Increase in cardiac output in mechanically ventilated patients with low tidal ventilation and/or low respiratory complianceCardiac output will be measured immediately after the end of the volume expansionThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026